PORCINE ANORGANIC BONE MINERAL— 510(k) K140714
Substantially EquivalentCollagen Matrix, Inc.
FDA 510(k) clearance K140714 for PORCINE ANORGANIC BONE MINERAL, Substantially Equivalent on 2014-07-16. 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
- Oakland, NJ, US
Recent devices under product code NPM
view allMore clearances from Collagen Matrix, Inc.
view allRecalls naming K140714
K-number listed on FDA's recall record- Z-0752-2019 — Porcine Anorganic Bone Mineral 4.0cc
- Z-1173-2016 — ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -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 -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-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 K140714.
Data sourced from openFDA. This site is unofficial and independent of the FDA.