← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

EBW — Controller, Foot, Handpiece And Cord

DEVICE CLASS
Class I
REGULATION
21 CFR 872.4200
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K251407Saeshin Precision Co., Ltd. · 510k2026-01-30
K251701Dentalez, Inc., Stardental Division · 510k2026-01-12
K251811Dentsply Sirona, Inc. · 510k2025-08-25
K231562Micro-Nx Co., Ltd. · 510k2025-07-18
K242646Guilin Aesthedent Medical Instruments Co., Ltd. · 510k2025-04-11

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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