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FDA PRODUCT CODE · CLASS II

NHA — Abutment, Implant, Dental, Endosseous

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3630
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
71
510(K)/PMA CLEARANCES
510k: 71
0
RECALL ENTRIES

Recent clearances

K261147JJGC Indústria e Comércio de Materiais Dentários S.A. · 510k2026-07-01
K261122Imagine Milling Technologies, LLC · 510k2026-06-27
K260061BioHorizons Implant Systems, Inc. · 510k2026-06-26
K253922JJGC Indústria e Comércio de Materiais Dentários S.A. · 510k2026-06-15
K254145Smart Denture Conversions, LLC · 510k2026-06-11
K260564Terrats Medical SL · 510k2026-06-09
K252904Sic Invent AG · 510k2026-06-03
K253774Elos Medtech Pinol A/S · 510k2026-05-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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