(127 days)
Not Found
No
The description focuses on the material properties and intended use of a dental composite resin, with no mention of AI or ML capabilities.
No
The device is a dental restorative material (composite resin) used to restore the form and function of teeth, not to treat a disease or medical condition.
No
The device is described as a restorative material (composite resin) for filling cavities, not for diagnosing conditions.
No
The device description clearly indicates it is a physical material (composite resin) used for dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The description clearly states the device is a "tooth colored dental restorative" used for filling cavities in teeth. This is a material applied directly to the body (in vivo) for structural restoration, not a test performed on a sample outside the body.
- Intended Use: The intended use is to "restore proper form and function of restored teeth," which aligns with a dental restorative material, not an IVD.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
Not Found
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PRISMA-FIL, ESTILUX POSTERIOR XR, BISFIL-1, OCCLUSIN, HERCULITE, P-50, PERTAC HYBRID, Z100, TETRIC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the word "parkell" in a bold, sans-serif font. The letters are all connected and have a rounded appearance. The word is in black and the background is white.
APR 11 1997
510(k) SUMMARY
| Submitter: | Nelson J. Gendusa, DDS
Director of Research
Parkell Products, Inc.
155 Schmitt Blvd.
Farmingdale, NY 11735
TEL: 516-249-1134
FAX: 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 and
Intended Use: | 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 |
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.