Company · US
Straumann USA
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2024. Name variants (Inc, Corp, punctuation) are merged.
80510(k) clearances (0 in 12 months)
28recalls (9 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 44 |
| NHA | Abutment, Implant, Dental, Endosseous | 39 |
| NDP | Accessories, Implant, Dental, Endosseous | 6 |
| OAT | Implant, Endosseous, Orthodontic | 4 |
| DZL | Screw, Fixation, Intraosseous | 2 |
| DZA | Drill, Dental, Intraoral | 1 |
| DZI | Drill, Bone, Powered | 1 |
| EGG | Attachment, Precision, All | 1 |
| ELB | Scaler, Rotary | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| JEY | Plate, Bone | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 1 |
| KJJ | Cleanser, Root Canal | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
| MQC | Mouthguard, Prescription | 1 |
| NQA | Biologic Material, Dental | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 11, 2024 | K241575 | Straumann® Anatomic Healing Abutments XC (AHA) Straumann USA, LLC | NHA |
| Jul 29, 2021 | K203753 | Straumann Surgical Cassettes Straumann USA, LLC | KCT |
| Feb 8, 2021 | K202942 | Straumann 4 mm Short Implants Straumann USA, LLC | DZE |
| Apr 6, 2020 | K192401 | Straumann Screw-Retained Abutments Straumann USA, LLC | NHA |
| Jun 17, 2019 | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems Straumann USA, LLC | DZE |
| Jan 19, 2018 | K171784 | Straumann Dental Implant System Straumann USA, LLC | DZE |
| Mar 8, 2017 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase A Straumann USA, LLC | DZE |
| Mar 4, 2016 | K151590 | Straumann RN Gold Abutment for Bridge Straumann USA, LLC | NHA |
| Jan 11, 2016 | K151328 | PURE Ceramic Implants Straumann USA | DZE |
| Sep 16, 2015 | K150899 | Straumann CARES Titanium Alloy (TAN) Abutment Straumann USA, LLC | NHA |
| Sep 11, 2015 | K151324 | Straumann Variobase for CEREC Straumann USA, LLC | NHA |
| Aug 10, 2015 | K151247 | NC Straumann Screw Retained Abutments Straumann USA, LLC | NHA |
| Aug 10, 2015 | K150814 | Straumann Screw-Retained Abutment Straumann USA, LLC | NHA |
| Aug 5, 2015 | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variob Straumann USA, LLC | NHA |
| Jul 24, 2015 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants Straumann USA, LLC | DZE |
| Jan 9, 2015 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Straumann USA, LLC | NHA |
| Aug 20, 2014 | K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT Straumann USA, LLC | DZE |
| Aug 14, 2014 | K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE Straumann USA, LLC | NHA |
| Aug 7, 2014 | K141871 | Straumann Bone Level NC Angled Screw Retained Abutments Straumann USA, LLC | NHA |
| Apr 17, 2014 | K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW Straumann USA, LLC | NHA |
| Feb 21, 2014 | K132219 | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, Straumann USA, LLC | NHA |
| Jan 15, 2014 | K132844 | STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES Straumann USA, LLC | NHA |
| Jun 28, 2013 | K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS Straumann USA | NHA |
| Jun 28, 2013 | K130724 | CODIAGNOSTIX IMPLANT PLANNING SOFTWARE Straumann USA | LLZ |
| Apr 29, 2013 | K130222 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC | DZE |
| Apr 10, 2013 | K123784 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC | DZE |
| Dec 12, 2012 | K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS Straumann USA | DZE |
| Nov 2, 2012 | K122192 | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM Straumann USA, LLC | NHA |
| Jun 6, 2012 | K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM Straumann USA | DZE |
| Jan 27, 2012 | K113606 | NNC GOLD ABUTMENT FOR BRIDGES Straumann USA | NHA |
| Jan 13, 2012 | K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT Straumann USA | NHA |
| Dec 28, 2011 | K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS Straumann USA | NHA |
| Nov 16, 2011 | K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM Straumann USA | NHA |
| Oct 3, 2011 | K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Sep 12, 2011 | K111724 | STRAUMANN TIBRUSH Straumann USA | ELB |
| Aug 12, 2011 | K110580 | NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS Straumann USA | NHA |
| Feb 12, 2010 | K093027 | STRAUMANN RC TEMPORARY ABUTMENTS Straumann USA | DZE |
| Feb 26, 2009 | K083550 | STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA | DZE |
| Oct 21, 2008 | K082532 | STRAUMANN GUIDED INSTRUMENTS Straumann USA | DZI |
| Mar 7, 2008 | K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS Straumann USA | NHA |
| Jan 22, 2008 | K073628 | SYNOCTA ABUTMENTS Straumann USA | NHA |
| Oct 15, 2007 | K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES Straumann USA | NHA |
| Sep 11, 2007 | K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS Straumann USA | NHA |
| Jul 11, 2007 | K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS Straumann USA | NHA |
| May 10, 2007 | K063789 | WN SYNOCTA GOLD ABUTMENT Straumann USA | NHA |
| Apr 12, 2007 | K061277 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING Straumann USA | NHA |
| Jan 12, 2007 | K063812 | STRAUMANN PREFGEL Straumann USA | KJJ |
| Aug 24, 2006 | K060958 | STRAUMANN NARROW NECK IMPLANTS Straumann USA | DZE |
| Jan 3, 2006 | K052272 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE Straumann USA | NHA |
| Apr 5, 2005 | K050515 | BONE BLOCK FIXATION SET Straumann USA, Inc. | DZL |
Newest 50 of 80.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | Straumann USA LLC GM Helix Implant, REF: 109.984; Open, Classified |
DZE | K163194 |
| Aug 11, 2026 | Straumann USA LLC Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form Open, Classified |
DZE | K140878 |
| Aug 10, 2026 | Straumann USA LLC GM Helix Implant, Endosseous Dental Implant
Article No. 109.984 Open, Classified |
NHA | K163194 |
| Apr 29, 2026 | Straumann USA LLC Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158.
Endosseous Dental Implant Abutments Open, Classified |
NHA | K222836 |
| Apr 29, 2026 | Straumann USA LLC Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.
Endosseous Dental Implant Abutments Open, Classified |
NHA | K242686 |
| Mar 24, 2026 | Straumann USA LLC Custom Abutment AS Ti, for Straumann RC, incl. TAN screw;
Catalog Number/Art.: 010.5438; Open, Classified |
NHA | K243278 |
| Mar 24, 2026 | Straumann USA LLC Custom Abutment Ti, for Straumann RC, incl. TAN screw;
Catalog Number/Art.: 027.4620; Open, Classified |
NHA | K072151 |
| Feb 9, 2026 | Straumann USA LLC WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM Open, Classified |
NDP | None listed |
| Nov 21, 2025 | Straumann USA LLC Emdogain;
Article Numbers: (1) 440.230V10, (2) 475.132V10; Open, Classified |
NQA | None listed |
| May 28, 2025 | Straumann USA LLC GM Helix Acqua Implant, Article Number: 140.985 Open, Classified |
DZE | K163194 |
| May 28, 2025 | Straumann USA LLC GM Helix Acqua Implant, Article Number: 140.984 Open, Classified |
DZE | K163194 |
| May 28, 2025 | Straumann USA LLC Plus Initial Drill, Article Number: 103.170; Open, Classified |
DZA | None listed |
| Apr 24, 2025 | Straumann USA LLC WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. Open, Classified |
NHA | K241575 |
| Apr 14, 2025 | Straumann USA LLC TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; Open, Classified |
NDP | None listed |
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5
Article Number: 138.107 Terminated |
DZE | K203382 |
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant
Item 138.089 Terminated |
DZE | K203382 |
| Jun 25, 2021 | Straumann USA LLC KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
Model (Ref) #: 4220005 Open, Classified |
MQC | K183598 |
| May 27, 2021 | Straumann USA LLC Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel
Article Number: 046.401. dental surgical instrument. Terminated |
NDP | None listed |
| Jan 15, 2015 | Straumann USA, LLC Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. Terminated |
NDP | None listed |
| Nov 6, 2014 | Straumann USA, LLC Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021.4308
Product Usage:
Dental implants are intended for surgical placement in maxillary and/or mandibular arches Terminated |
DZE | K121131 |
| Oct 23, 2014 | Straumann USA, LLC Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021 .5308
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to pr Terminated |
DZE | K140878 |
| Aug 8, 2012 | Straumann USA, LLC Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant
Article Number: 027.2650
Product Usage:
Dental implants are intended for surgical placement in maxillary and/o Terminated |
NHA | K081005 |
| Mar 30, 2012 | Straumann USA, LLC Straumann Standard Plus Implant 04.8mm Wide Neck
SLA 10mm
Article Number: 043.652S.
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for p Terminated |
NDP | K033922 |
| Apr 30, 2008 | Straumann Usa, Llc Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810 Terminated |
EGG | K071585 |
| Dec 4, 2007 | Straumann USA LLC Straumann Palatal Implant , 4.8 L 4.2 mm,
Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 Terminated |
OAT | K060062 |
| Dec 4, 2007 | Straumann USA LLC Straumann Palatal Implant , 04.1 L 4.2 mm,
Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 Terminated |
OAT | K060062 |
| Dec 9, 2004 | The Straumann Company Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel
Ref. Number: 044.084 Terminated |
NDP | None listed |
| Jul 20, 2004 | The Straumann Company Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel
Article No. 044.088 Terminated |
DZE | None listed |