510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122894Substantially Equivalent

Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic

Geistlich Pharma AG, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122894 is the FDA 510(k) clearance record for GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC, a class II device, cleared for Geistlich Pharma AG on under FDA product code NPM (Bone Grafting Material, Animal Source). FDA's definition for product code NPM reads: "A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw". FDA records list 43 510(k) clearances for Geistlich Pharma AG, from to . As of , FDA records show no recalls naming K122894.

Clearance record

Decision date
Received
(148 days to decision)
Product code
NPM Bone Grafting Material, Animal Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Geistlich Pharma AG 555 Twelfth St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPM

Trailing 12 months
2 clearances under product code NPM 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 NPM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260