510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983450Substantially Equivalent

Starryshine Gauze Sponge

T.C. Dental Products, Inc., Walnut CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983450 is the FDA 510(k) clearance record for STARRYSHINE GAUZE SPONGE, cleared for T.C. Dental Products, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list one 510(k) clearance for T.C. Dental Products, Inc. As of , FDA records show no recalls naming K983450.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
T.C. Dental Products, Inc. 20957 Currier Rd., #E, Walnut CA
510(k) summary
Summary
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

FDA records show no clearances under product code EFQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFQ, 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