STANDARD S32
FDA 510(k) clearance K912308 · decided 1991-08-09
Clearance details
- K-number
- K912308
- Device name
- STANDARD S32
- Applicant
- Metalor Dental USA Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-21
- Decision date
- 1991-08-09
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- EJS
- Device class
- 2
- Regulation number
- 872.3060
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Rockville Centre, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRIGHT GOLD XH (K041433) | Ivoclar Vivadent, Inc. | 2004-08-19 |
| SIMIDUR SUPERIOR (K040436) | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 |
| STERNGOLD 1, MODEL 1127781 (K022252) | Sterngold | 2002-09-19 |
| ECO E4 (K022469) | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 |
| STERNGOLD 66, MODEL #1180230 (K021367) | Sterngold | 2002-05-16 |
| SIMIDUR S1S (K020195) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR S2 (K020192) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| SIMIDUR KF PLUS (K020194) | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 |
| D.SIGN 84 (K014042) | Ivoclar Vivadent, Inc. | 2002-02-22 |
| D.SIGN 59 (K013809) | Ivoclar Vivadent, Inc. | 2002-02-07 |
| D.SIGN 53, MODEL NA1012204 (K014082) | Ivoclar Vivadent, Inc. | 2002-01-30 |
| DUO PAL 6, ORDER-NO.: 2154 (K012841) | Wieland Edelmetalle GmbH & Co. | 2001-11-20 |
Recalls involving this device
No recalls on record reference this clearance.