VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
FDA 510(k) clearance K070991 · decided 2007-06-01
Clearance details
- K-number
- K070991
- Device name
- VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310
- Applicant
- Vita
- Decision
- Substantially Equivalent
- Date received
- 2007-04-09
- Decision date
- 2007-06-01
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- EBG
- Device class
- 2
- Regulation number
- 872.3770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vita
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dura-Arch (K261261) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| “FLNT Base” and “FLNT Temp” (K253380) | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| TempFIT Temporary Crown and Bridge Resin (K251271) | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| DentaTOOTH (K243370) | Asiga Pty, Ltd. | 2025-05-05 |
| Evoblock, Perléon (K243621) | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| TEMP MASTER, PMMA-based dental resin (K243951) | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| PrimmaArt (K231859) | Dentscare Ltda | 2024-11-26 |
| Digital Temp (K242559) | Sprintray, Inc. | 2024-11-26 |
| Premium Teeth Resin (K240538) | Formlabs Ohio, Inc. | 2024-07-19 |
| Fixtemp® C&B 4:1 (K241226) | Dreve Denatmid GmbH | 2024-05-31 |
| dima Print Teeth & Temp (K233868) | Kulzer, LLC | 2024-05-23 |
| PMMA BLOCK (K223706) | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
Recalls involving this device
No recalls on record reference this clearance.