510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790935Substantially Equivalent

Delton* Pit and Fissure Sealent

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

K790935 is the FDA 510(k) clearance record for DELTON* PIT AND FISSURE SEALENT, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K790935.

Clearance record

Decision date
Received
(79 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
Device class
Class II
Review panel
Dental
Applicant
Johnson & Johnson Professionals, Inc. 325 Paramount Dr., Raynham MA
Third party review
No

Clearances, product code EBC

Trailing 12 months
1 clearance under product code EBC in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260