Applicator, Resin
The Resin Applicator is a dental device used to apply dental resins, adhesives, or bonding agents to tooth surfaces or restorations during dental procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KXR, regulated under 21 CFR 872.3140, in the Dental medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KXR
- Device Class
- FDA class 1
- Regulation Number
- 872.3140
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832662 | DENTAL SYRINGE SYSTEM-VARIOUS STYLES | Oct 04, 1983 | Substantially Equivalent | Centrix, Inc. |
| K781098 | BRUSH, APPLICATOR | Sep 29, 1978 | Substantially Equivalent | 3M Company |
| K770160 | CERAMIST BRUSH | Jan 31, 1977 | Substantially Equivalent | Deringer-Ney, Inc. |
FEI Numbers
This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.