ClearanceBrief
Panels › Dental › Product code NHA · Class 2

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)
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Top companies in NHA

DateFirm and productCodeLinked 510(k)
Aug 10, 2026Straumann USA LLC
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Open, Classified
NHAK163194
Apr 29, 2026Straumann USA LLC
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Open, Classified
NHAK222836
Apr 29, 2026Straumann USA LLC
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Open, Classified
NHAK242686
Mar 24, 2026Straumann USA LLC
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Open, Classified
NHAK243278
Mar 24, 2026Straumann USA LLC
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Open, Classified
NHAK072151
Nov 3, 2025Prismatik 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
NHAK142115
Sep 3, 2025Preat Corp
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Open, Classified
NHAK183518
Jul 10, 2025Preat Corp
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Open, Classified
NHAK220823
Jun 18, 2025Preat 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
NHAK183518
Apr 24, 2025Straumann USA LLC
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Open, Classified
NHAK241575
Mar 5, 2025Hiossen 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
NHAK161689
Mar 5, 2025Hiossen 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
NHAK130662
Mar 5, 2025Hiossen 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
NHAK161689
Mar 5, 2025Hiossen 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
NHAK130662
Mar 5, 2025Hiossen 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
NHAK130662
Mar 5, 2025Hiossen 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
NHAK130662
Feb 5, 2025DDS Lab
Temporary Titanium Abutments
Open, Classified
NHAK071638
K093321 +2
Jul 8, 2024Preat 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
NHAK220823
Mar 20, 2024Preat Corp
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Open, Classified
NHAK183518
Oct 24, 2023Preat Corp
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Open, Classified
NHAK220823
Oct 24, 2023Preat Corp
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Open, Classified
NHAK220823
Oct 24, 2023Preat Corp
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Open, Classified
NHAK220823
Jun 29, 2023Implant 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
NHAK223535
Mar 24, 2023Preat Corp
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Open, Classified
NHAK220823
Mar 29, 2021Nobel 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
NHAK132746
Mar 29, 2021Nobel 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
NHAK132746
Mar 29, 2021Nobel 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
NHAK132746
Mar 29, 2021Nobel 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
NHAK132746
Mar 29, 2021Nobel 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
NHAK132746
Aug 31, 2020Biomet 3i, LLC
CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Terminated
NHAK052648
Aug 31, 2020Biomet 3i, LLC
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Terminated
NHAK052648
Feb 10, 2020Implant Direct Sybron Manufacturing LLC
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Terminated
NHAK081396
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
Terminated
NHAK072642
Jan 10, 2020Biomet 3i, LLC
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Terminated
NHAK072642

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