← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KIF — Resin, Root Canal Filling

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3820
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K261415Guilin Kevin Peter Technology Co., Ltd. · 510k2026-06-29
K253167Mediclus Co., Ltd. · 510k2026-01-12
K252890Kerr Corporation · 510k2026-01-07
K251465Enpuno Biotechnology Co., Ltd. · 510k2025-09-25
K252285Vericom Co., Ltd. · 510k2025-09-19
K251884Mediclus Co., Ltd. · 510k2025-08-22
K251390Voco GmbH · 510k2025-07-03
K250710Enpuno Co., Ltd. · 510k2025-06-11

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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