DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
FDA 510(k) clearance K192381 · decided 2020-02-18
Clearance details
- K-number
- K192381
- Device name
- DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
- Applicant
- Scientific Pharmaceuticals
- Decision
- Substantially Equivalent
- Date received
- 2019-08-30
- Decision date
- 2020-02-18
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Pomona, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.