510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863500Substantially Equivalent

Stainless Steel Den. Crown Remover & Ama./comp.car

Pacific Union Dental, Inc., Silver Spring MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863500 is the FDA 510(k) clearance record for STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR, a class I device, cleared for Pacific Union Dental, Inc. on under FDA product code EIS (Remover, Crown). FDA records list 5 510(k) clearances for Pacific Union Dental, Inc., from to . As of , FDA records show no recalls naming K863500.

Clearance record

Decision date
Received
(13 days to decision)
Product code
EIS Remover, Crown
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Pacific Union Dental, Inc. P.O. Box 2025, Silver Spring MD
Third party review
No

Clearances, product code EIS

Trailing 12 months

FDA records hold no clearances under product code EIS in the trailing twelve months.

FDA records show no clearances under product code EIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260