PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
FDA 510(k) clearance K150704 · decided 2015-08-21
Clearance details
- K-number
- K150704
- Device name
- PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
- Applicant
- Kuraray Noritake Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-18
- Decision date
- 2015-08-21
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- EMA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chiyoda Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.