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K Number
K012423
Device Name
MUCOGRAFT
Manufacturer
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE
Date Cleared
2003-01-24

(543 days)

Product Code
NPL
Regulation Number
872.3930
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MUCOGRAFT® is indicated for:

  • simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; -
  • augmentation around implants placed in immediate extraction sockets; -
  • augmentation around implants placed in delayed extraction sockets; -
  • localized ridge augmentation for later implantation; -
  • alveolar ridge reconstruction for prosthetic treatment; -
  • filling of bone defects after root resection, cystectomy, removal of retained teeth;
  • guided bone regeneration in dehiscence defects.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design details (like sample size, data provenance, expert qualifications, or adjudication methods), or any mention of AI assistance. The document is a 510(k) premarket notification letter regarding a dental bone grafting material called MUCOGRAFT, indicating its substantial equivalence to a predicate device and specifying its indications for use. It does not include the type of performance study data you are requesting.

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.