← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K964342 # CYTOPLAST GBR (K964342) _Osteogenics Co. · LYC · Mar 11, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K964342 ## Device Facts - **Applicant:** Osteogenics Co. - **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md) - **Decision Date:** Mar 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3930 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects. ## Device Story Cytoplast™ GBR is a non-absorbable barrier membrane; composed of nanoporous high-density polytetrafluoroethylene (n-PTFE) film; 250-micron nominal thickness. Used in dental surgery to facilitate bone regeneration by acting as a space-making barrier over periodontal defects. Supplied sterile in various shapes/sizes. Implanted by clinicians; provides physical barrier to prevent soft tissue ingrowth into bone defect sites; promotes bone healing. Biocompatibility established via history of PTFE use in vascular/cardiovascular implants. ## Clinical Evidence No clinical data provided; substantial equivalence based on identical composition and function to predicate devices and established biocompatibility of PTFE material. ## Technological Characteristics Material: Nanoporous high-density polytetrafluoroethylene (n-PTFE) film. Dimensions: 250-micron nominal thickness. Form factor: Various shapes/sizes. Sterilization: Sterile. Energy source: None (passive implant). ## 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 - Gore-Tex™ Regenerative Material ([K922627](/device/K922627.md)) - TefGen-FD ([K935137](/device/K935137.md)) - Imtec Biobarrier Membrane ([K950306](/device/K950306.md)) ## 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} K964342 MAR 11 1997 # 510(k) SUMMARY ## I. ADMINISTRATIVE Submitter: Osteogenics Co. 3234 64th Street Lubbock, TX 79413 (806) 792-2311 Contact Person: Barry K. Bartee, DDS Date of Preparation: January 29, 1997 ## II. DEVICE NAME Proprietary Name: Cytoplast™ GBR Common Name: Non-Absorbable Barrier Membrane Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation. ## III. PREDICATE DEVICES Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation) ## IV. DEVICE DESCRIPTION The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches. The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic. ## V. INTENDED USE A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects. K964342 Amendment: Cytoplast™ GBR {1} # VI. COMPARISON TO PREDICATE DEVICES The Cytoplast™ GBR Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material, TefGen-FD, and the Imtec Biobarrier Membrane. Accordingly, Osteogenics Co. concluded that the Cytoplast™ GBR Non - Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices. K964342 Amendment: Cytoplast™ GBR --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K964342](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K964342) **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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