510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K871591Substantially Equivalent

Ormco Gel-Etch

Scientific Pharmaceuticals, Inc., Duarte CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871591 is the FDA 510(k) clearance record for ORMCO GEL-ETCH, a class II device, cleared for Scientific Pharmaceuticals, Inc. on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list 73 510(k) clearances for Scientific Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K871591.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DYH Adhesive, Bracket And Tooth Conditioner, Resin
Regulation
21 CFR 872.3750
Device class
Class II
Review panel
Dental
Applicant
Scientific Pharmaceuticals, Inc. 1828 Evergreen St., Duarte CA
Third party review
No

Clearances, product code DYH

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