510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000996Substantially Equivalent

Trubyte Denture Cleanser/polishing Compound

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000996 is the FDA 510(k) clearance record for TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND, a class I device, cleared for Dentsply Intl. on under FDA product code EFT (Cleanser, Denture, Over The Counter). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K000996.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EFT Cleanser, Denture, Over The Counter
Regulation
21 CFR 872.3520
Device class
Class I
Review panel
Dental
Applicant
Dentsply Intl. 570 W. College Ave., York PA
510(k) summary
Summary
Third party review
No

Clearances, product code EFT

Trailing 12 months

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

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