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
K043034Substantially Equivalent

Osteoguide Anorganic Bone Mineral Products

Collagen Matrix, Inc, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043034 is the FDA 510(k) clearance record for OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS, a class II device, cleared for Collagen Matrix, Inc. 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 47 510(k) clearances for Collagen Matrix, Inc., from to . As of , FDA records show 3 recalls naming K043034.

Clearance record

Decision date
Received
(274 days to decision)
Product code
NPM Bone Grafting Material, Animal Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Collagen Matrix, Inc. 509 Commerce St., Franklin Lakes NJ
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