510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042197Substantially Equivalent

Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration

Ed. Geistlich Soehne AG Fuer Chemische Industrie, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042197 is the FDA 510(k) clearance record for BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION, a class II device, cleared for Ed. Geistlich Soehne AG Fuer Chemische Industrie on under FDA product code NPL (Barrier, Animal Source, Intraoral). FDA's definition for product code NPL reads: "An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed...". FDA records list 6 510(k) clearances for Ed. Geistlich Soehne AG Fuer Chemische Industrie, from to . As of , FDA records show no recalls naming K042197.

Clearance record

Decision date
Received
(94 days to decision)
Product code
NPL Barrier, Animal Source, Intraoral
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Ed. Geistlich Soehne AG Fuer Chemische Industrie 1301 K St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPL

Trailing 12 months
3 clearances under product code NPL in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NPL, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260