OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS— 510(k) K043034
Substantially EquivalentCollagen Matrix, Inc.
FDA 510(k) clearance K043034 for OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS, Substantially Equivalent on 2005-08-04. Applicant: Collagen Matrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Collagen Matrix, Inc.
- Product code
- Code NPM
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code NPM
view allMore clearances from Collagen Matrix, Inc.
view allRecalls naming K043034
K-number listed on FDA's recall record- Z-0823-2022 — NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
- Z-1096-2016 — NuOSS Cancellous Intended for use in dental surgery.
- Z-1097-2016 — NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043034.
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