← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K960361 # PERMAMESH-D HYDROXYLAPATITE MATRIX (K960361) _Ceramed Corp. · LYC · Apr 15, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K960361 ## Device Facts - **Applicant:** Ceramed Corp. - **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md) - **Decision Date:** Apr 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3930 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use Bone filling and/or augmentation of the alveolar ridge. ## Device Story PermaMesh-D is a synthetic hydroxylapatite bone graft material; composed of high-purity, radiopaque, 1000-micron diameter beads; organized into a flat, flexible, cloth-like woven sheet using absorbable suture. Device serves as a scaffold for bone filling and augmentation of the alveolar ridge. Implanted by clinicians during surgical procedures to support bone regeneration. ## Clinical Evidence No clinical data provided; substantial equivalence based on material composition and physical characteristics. ## Technological Characteristics Material: 100% synthetic hydroxylapatite (HA) beads. Conforms to ASTM F1185 for trace elements. Calcium to phosphorus mole ratio: 1.68. Form factor: woven sheet/cloth-like structure held by absorbable suture. Radiopaque. ## Regulatory Identification Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. ## Special Controls *Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. ## Predicate Devices - PermaRidge - PermaMesh ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUMMARY K960361 APR 15 1996 K960361 January 22, 1996 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. 1. **Submitter:** CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800 Contact Person: Barbara A. Watson 2. **Device Name:** PermaMesh-D Hydroxylapatite Matrix, 1000 microns Classification Name: Endosseous implant for bone filling and/or augmentation 3. **Predicate Device:** PermaRidge PermaMesh 4. **Device Description:** PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture. 5. **Intended Use:** Bone filling and/or augmentation of the alveolar ridge. 6. **Comparison of Product Characteristics:** PermaMesh-D consists of 100% synthetic hydroxylapatite beads strung on absorbable suture. X-ray diffraction shows PermaMesh-D beads to be 100% HA. The hydroxylapatite component of PermaMesh-D conforms to ASTM Standard # F1185, "Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants", for trace elements. Typical calcium to phosphorus mole ratio is 1.68. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K960361](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K960361) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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