SPIRIT MB
FDA 510(k) clearance K943245 · decided 1994-08-23
Clearance details
- K-number
- K943245
- Device name
- SPIRIT MB
- Applicant
- Sybron Dental Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-06
- Decision date
- 1994-08-23
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DYW
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Glendora, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Pr recall (Z-1330-2014) | Ormco/Sybronendo | 2014-04-04 |
| Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an recall (Z-0200-2012) | Ormco Corporation | 2011-11-16 |
| Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an recall (Z-0201-2012) | Ormco Corporation | 2011-11-16 |