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
K053329Substantially Equivalent

Korlex-Gr Gingival Retraction Paste

Biotech One, Inc., Laguna Niguel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053329 is the FDA 510(k) clearance record for KORLEX-GR GINGIVAL RETRACTION PASTE, cleared for Biotech One, Inc. on under FDA product code MVL (Cord, Retraction). FDA records list 2 510(k) clearances for Biotech One, Inc., from to . As of , FDA records show no recalls naming K053329.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MVL Cord, Retraction
Device class
Unclassified
Review panel
Unknown
Applicant
Biotech One, Inc. 92 Costa Brava, Laguna Niguel CA
510(k) summary
Statement
Third party review
No

Clearances, product code MVL

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