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External Cleaning Solution

Page Type
Product Code
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Physical State
Solution consists of a gel or liquid that is applied directly to the dental restoration.
Technical Method
Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
Target Area
The target area of the body is a tooth which will have the dental restoration applied to it.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
872.3260
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3260 Cavity varnish

§ 872.3260 Cavity varnish.

(a) Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

(b) Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]

External Cleaning Solution

Page Type
Product Code
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Physical State
Solution consists of a gel or liquid that is applied directly to the dental restoration.
Technical Method
Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
Target Area
The target area of the body is a tooth which will have the dental restoration applied to it.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
872.3260
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3260 Cavity varnish

§ 872.3260 Cavity varnish.

(a) Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

(b) Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]