Company ยท US
Straumann Manufacturing, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2009. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2009 | K092814 | STRAUMANN DENTAL ABUTMENTS Straumann Manufacturing, Inc. | NHA |
| Feb 26, 2009 | K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS Straumann Manufacturing, Inc. | DZE |
| Apr 30, 2008 | K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS Straumann Manufacturing, Inc. | NHA |
| Sep 20, 2007 | K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) Straumann Manufacturing, Inc. | NHA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2018 | Straumann Manufacturing, Inc. Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a Terminated |
DZE | K163194 |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 Terminated |
NQA | None listed |
| Mar 23, 2018 | Straumann Manufacturing, Inc. Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W Terminated |
NQA | None listed |
| Nov 23, 2016 | Straumann Manufacturing, Inc. Straumann Twist Drill PRO 4.2mm,long,41mm,SS-Non sterile. Dental implant accessory
Article Number: 044.255
Dental implants drill accessory is intended to prepare osteotomy site for surgical dental Terminated |
NDP | None listed |
| Nov 23, 2016 | Straumann Manufacturing, Inc. Straumann Drill 1, short, 2.2mm, l 33.0mm, SS-Non sterile.
Dental implant accessory
Article Number: 044.210
Dental implants drill accessory is intended to prepare osteotomy site for surgical dental Terminated |
NDP | None listed |
| Jul 14, 2016 | Straumann Manufacturing, Inc. Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP
Article Number: 021.4512 Terminated |
DZE | K150938 |
| Jul 14, 2016 | Straumann Manufacturing, Inc. Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP
Article Number: 021.4510 Terminated |
DZE | K150938 |
| Sep 13, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill.
Imaging processing System Terminated |
LLZ | K071636 |
| Mar 7, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, dental implant planning system.
Software Version 7.0 including updates 7.0.2 and 7.0.2.10 Terminated |
LLZ | K071636 |
| Nov 4, 2010 | Straumann Manufacturing Inc. Straumann T-Sleeve 2.8mm, height 6mm, guided
Article Number: 034.055V46
Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site. Terminated |
NDP | None listed |
| Aug 6, 2010 | Straumann Manufacturing Inc. Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021.
Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental Terminated |
NDP | None listed |
| Sep 16, 2008 | Straumann Manufacturing Inc. Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of Terminated |
DZE | None listed |
| May 4, 2006 | Straumann Manufacturing Inc. Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm
Ref: 048.043 Terminated |
DZE | K960634 |
| Mar 9, 2006 | Straumann Manufacturing Inc. Thermoplastic templates, free-end situation
Catalog Number: 040.527 Terminated |
DZJ | None listed |
| Mar 9, 2006 | Straumann Manufacturing Inc. Thermoplastic templates, single tooth
Catalog Number: 040.526 Terminated |
DZJ | None listed |
| Jul 7, 2005 | Straumann Manufacturing Inc RN synOcta Meso Abutment, crown margin 8.0mm, Ti
Article: 048.560 Terminated |
DZE | K020096 |