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
K881992Substantially Equivalent

Syrette

Oratec Corp., Herndon VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881992 is the FDA 510(k) clearance record for SYRETTE, a class I device, cleared for Oratec Corp. on under FDA product code EKJ (Burnisher, Operative). FDA records list one 510(k) clearance for Oratec Corp. As of , FDA records show no recalls naming K881992.

Clearance record

Decision date
Received
(75 days to decision)
Product code
EKJ Burnisher, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Oratec Corp. 485 Spring Park Pl., Herndon VA
Third party review
No

Clearances, product code EKJ

Trailing 12 months

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

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