510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172398Substantially Equivalent

DENTCA DENTURE Teeth

Dentca, Inc., Torrance CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K172398 is the FDA 510(k) clearance record for DENTCA DENTURE Teeth, a class II device, cleared for Dentca, Inc. on under FDA product code PZY (Additively Manufactured, Preformed, Resin Denture Tooth). FDA's definition for product code PZY reads: "For the fabrication of preformed denture teeth for use in a denture base". FDA records list 6 510(k) clearances for Dentca, Inc., from to . As of , FDA records show no recalls naming K172398.

Clearance record

Decision date
Received
(106 days to decision)
Product code
PZY Additively Manufactured, Preformed, Resin Denture Tooth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Dentca, Inc. 357 Van Ness Way, Suite 250, Torrance CA
510(k) summary
Statement
Third party review
No

Clearances, product code PZY

Trailing 12 months

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

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