← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DZE — Implant, Endosseous, Root-Form

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3640
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
58
510(K)/PMA CLEARANCES
510k: 58
0
RECALL ENTRIES

Recent clearances

K251188Uniqa Dental, Ltd. · 510k2026-06-25
K251232Megagen Implant Co., Ltd. · 510k2026-06-18
K250806A.B. Dental Devices , Ltd. · 510k2026-06-18
K260006Inosys, Inc. · 510k2026-06-17
K252731Promimic AB · 510k2026-05-12
K252031Adin Dental Implant Systems , Ltd. · 510k2026-03-23
K253334Izenimplant Co., Ltd. · 510k2026-03-16
K252168Institut Straumann AG · 510k2026-03-10

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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