ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
FDA 510(k) clearance K881253 · decided 1988-04-21
Clearance details
- K-number
- K881253
- Device name
- ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
- Applicant
- Dentalez Group
- Decision
- Substantially Equivalent
- Date received
- 1988-03-23
- Decision date
- 1988-04-21
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lancaster, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air d recall (Z-2177-2024) | Dental EZ Group Star Dental Division | 2024-06-24 |
| Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1 recall (Z-2178-2024) | Dental EZ Group Star Dental Division | 2024-06-24 |