510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955646Substantially Equivalent

Vicryl Peridontal Mesh

Ethicon, Inc, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955646 is the FDA 510(k) clearance record for VICRYL PERIDONTAL MESH, a class II device, cleared for ETHICON, Inc. on under FDA product code NPK (Barrier, Synthetic, Intraoral). FDA's definition for product code NPK reads: "A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials". FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K955646.

Clearance record

Decision date
Received
(160 days to decision)
Product code
NPK Barrier, Synthetic, Intraoral
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
ETHICON, Inc. P.O Box 151, Rte. 22 W., Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code NPK

Trailing 12 months

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

FDA records show no clearances under product code NPK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260