(81 days)
Not Found
No
The summary describes a synthetic bone graft material and its physical form, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a bone filling and/or augmentation material for the alveolar ridge, which is a structural rather than a therapeutic function.
No
The device is described as a bone filling and/or augmentation material for the alveolar ridge, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a synthetic form of hydroxylapatite in a woven sheet form, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Bone filling and/or augmentation of the alveolar ridge." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a synthetic material used for bone grafting. It is implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis.
Therefore, PermaMesh-D is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bone filling and/or augmentation of the alveolar ridge.
Product codes
Not Found
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
alveolar ridge
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
PermaRidge, PermaMesh
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.