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K Number
K974399
Device Name
BIO-OSS COLLAGEN
Manufacturer
GEISTLICH-PHARMA
Date Cleared
1998-09-16

(299 days)

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

Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
rilling 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 peri-implant defects in-conjunction with products-intended for Guided Bone Regeneration(GBR)

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Bio-Oss Collagen." It does not contain information about the acceptance criteria and study proving device performance as requested. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample sizes or data provenance for the test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about a standalone performance study.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.