510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911285Substantially Equivalent

Pulpdent Polyamide Dentin Liner

Pulpdent Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911285 is the FDA 510(k) clearance record for PULPDENT POLYAMIDE DENTIN LINER, a class I device, cleared for Pulpdent Corp. on under FDA product code EME (Punch, Biopsy, Surgical). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K911285.

Clearance record

Decision date
Received
(204 days to decision)
Product code
EME Punch, Biopsy, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
Third party review
No

Clearances, product code EME

Trailing 12 months

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

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