Abutment, Implant, Dental, Endosseous
Regulation 872.3630
30510(k)s in 12 months (716 all time)
6recalls in 12 months (225 all time)
194recalls that name a 510(k)
Top companies in NHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i | 19 | 174 |
| Nobel Biocare AB | 49 | 7 |
| Institut Straumann AG | 47 | 0 |
| Straumann USA | 32 | 7 |
| Dentsply Sirona | 23 | 0 |
| Terrats Medical SL | 21 | 0 |
| Zimmer Dental, Inc. | 21 | 0 |
| Prismatik Dentalcraft, Inc. | 19 | 1 |
| Osstem Implant Co., Ltd. | 18 | 0 |
| Atlantis Components, Inc. | 17 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 3, 2025 | Prismatik Dentalcraft, Inc. Brand Name: Inclusive
Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm
Model/Catalog Number: 70-1047-COM0117 Open, Classified |
NHA | K142115 |
| Sep 3, 2025 | Preat Corp NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 Open, Classified |
NHA | K183518 |
| Jul 10, 2025 | Preat Corp Preat, Astra EV-compatible 4.2mm Digital Analog
REF: 9006603 (single) and 9006603-10(10 pack), Rx Only Open, Classified |
NHA | K220823 |
| Jun 18, 2025 | Preat Corp Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F
Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch Open, Classified |
NHA | K183518 |
| Apr 24, 2025 | Straumann USA LLC WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. Open, Classified |
NHA | K241575 |
| Mar 5, 2025 | Hiossen Inc. Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over Open, Classified |
NHA | K161689 |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: E Open, Classified |
NHA | K130662 |
| Mar 5, 2025 | Hiossen Inc. Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over Open, Classified |
NHA | K161689 |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: Open, Classified |
NHA | K130662 |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: Open, Classified |
NHA | K130662 |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
GA4515MP
Model/Catalog Open, Classified |
NHA | K130662 |
| Feb 5, 2025 | DDS Lab Temporary Titanium Abutments Open, Classified |
NHA | K071638 K093321 +2 |
| Jul 8, 2024 | Preat Corp 9006767 Astra EV 4.8mm Milled Titanium Abutment
Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. Open, Classified |
NHA | K220823 |
| Mar 20, 2024 | Preat Corp Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 Open, Classified |
NHA | K183518 |
| Oct 24, 2023 | Preat Corp Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | K220823 |
| Oct 24, 2023 | Preat Corp Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | K220823 |
| Oct 24, 2023 | Preat Corp Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | K220823 |
| Jun 29, 2023 | Implant Direct Sybron Manufacturing LLC LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE;
LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE;
LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE;
LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE
LEGACY S Open, Classified |
NHA | K223535 |
| Mar 24, 2023 | Preat Corp Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 Open, Classified |
NHA | K220823 |
| Mar 29, 2021 | Nobel Biocare Procera LLC NPr FCZImp Crwn ASC CC NP CAD 1-25 s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s che Terminated |
NHA | K132746 |
| Mar 29, 2021 | Nobel Biocare Procera LLC NPr FCZImp Crwn ASC CC RP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s che Terminated |
NHA | K132746 |
| Mar 29, 2021 | Nobel Biocare Procera LLC NPr FCZImp Crwn ASC CC NP CAD 1-25 s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s che Terminated |
NHA | K132746 |
| Mar 29, 2021 | Nobel Biocare Procera LLC NPr FCZImp Crwn ASC CC RP CAD 1-25s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chew Terminated |
NHA | K132746 |
| Mar 29, 2021 | Nobel Biocare Procera LLC NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s che Terminated |
NHA | K132746 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM
Reference Number: IEDAT6 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM
Reference Number: IEDAT5 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: IEDAT4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 5.0MM
Reference Number: IEDAN5 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 4.1MM
Reference Number: IEDAN4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: EDAT4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model
Reference Numbers: 3DPMSER, 3DPMSERQ Terminated |
NHA | K052648 |
| Feb 10, 2020 | Implant Direct Sybron Manufacturing LLC SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Terminated |
NHA | K081396 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number:
IEHA574 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA566 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA563 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H)
Reference Number: IEHA554 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H)
Reference Number: IEHA553 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H)
Reference Number: IEHA474 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA466 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA464 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA463 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H)
Reference Number: IEHA456 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
Reference Number: IEHA454 Terminated |
NHA | K072642 |
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