ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

• K Number: K955838
• Device Name: ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)
• Manufacturer: ATRIX LABORATORIES, INC.
• Date Cleared: 1996-03-21 ( 90 days)
• Product Code: NPK
• Regulation Number: 872.3930
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a substantially equivalent determination for a medical device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

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• The specific acceptance criteria for the device's performance.
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• Whether any comparative effectiveness studies were performed.

Regulation Number and Section

§ 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.