510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930504Substantially Equivalent

New Dentin Primer

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

K930504 is the FDA 510(k) clearance record for NEW DENTIN PRIMER, a class II device, cleared for Dentsply Intl. on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K930504.

Clearance record

Decision date
Received
(115 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Dentsply Intl. 570 W. College Ave., York PA
510(k) summary
Statement
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260