(81 days)
Bone filling and/or augmentation of the alveolar ridge.
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.
I am sorry, but the provided text is a 510(k) summary for a medical device (PermaMesh-D Hydroxylapatite Matrix) and does not contain any information about acceptance criteria, device performance studies, or efficacy data as it relates to software or AI algorithms.
The document describes the device's characteristics, intended use, and comparison to predicate devices, focusing on its material composition and physical form. It does not touch upon any computational, diagnostic, or interpretive performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided input.
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9603/01
APR
1 5 1996
510(k) SUMMARY
January 22, 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- Submitter: し、 CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800 Contact Person: Barbara A. Watson
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- Device Name: PermaMesh-D Hydroxylapatite Matrix, 1000 microns Classification Name: Endosseous implant for bone filling and/or augmentation
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- Predicate Device: PermaRidge PermaMesh
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- 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.
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- Intended Use: Bone filling and/or augmentation of the alveolar ridge.
- Q. 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.
§ 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.