(127 days)
May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth. The above-cited material contains materials that are common in dental ine above of consard consard when used according to directions. Use resind and poss no may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is polymerizable with currently available visible light curing devices.
May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth. The above-cited material contains materials that are common in dental ine above of consard consard when used according to directions. Use resind and poss no may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is polymerizable with currently available visible light curing devices.
This 510(k) premarket notification for Parkell's Hybrid Composite Resin is for a dental restorative material, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment (which are all relevant to AI/ML device validation) is not included in this document.
The provided text describes a traditional medical device (dental composite resin) and focuses on its chemical composition, intended use, and equivalence to existing products. It does not involve any algorithms, AI, or machine learning that would necessitate the type of performance evaluation outlined in your request.
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APR 11 1997
510(k) SUMMARY
| Submitter: | Nelson J. Gendusa, DDSDirector of ResearchParkell Products, Inc.155 Schmitt Blvd.Farmingdale, NY 11735TEL: 516-249-1134FAX: 516-249-1242 |
|---|---|
| Contact: | Same as above. |
| Date of Submission: | November 25, 1996 |
| Trade Name: | Hybrid Composite Resin |
| Common Name: | Hybrid Composite Material |
| Classification Name: | Tooth Shade Resin Material (21 CFR §872.3690) |
| Equivalence: | PRISMA-FIL; ESTILUX POSTERIOR XR; BISFIL-1;OCCLUSIN; HERCULITE; P-50; PERTAC HYBRID;Z100; TETRIC |
| Description andIntended Use: | May be described as a radiopaque, light-cured,hybrid composite resin for use as a tooth coloreddental restorative in Class I, II, III, IV and Vcavities. It is contoured and polished using |
indicated, the material is recommended for restoring proper form and function of restored teeth. The above-cited material contains materials that are common in dental ine above of consard consard when used according to directions. Use resind and poss no may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is
currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as
polymerizable with currently available visible light curing devices.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.