510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822451Substantially Equivalent

Aurafill* Dental Restorative Bonding Ag.

Johnson & Johnson Professionals, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822451 is the FDA 510(k) clearance record for AURAFILL* DENTAL RESTORATIVE BONDING AG., a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K822451.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Johnson & Johnson Professionals, Inc. 325 Paramount Dr., Raynham MA
Third party review
No

Clearances, product code KLE

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