OMNI-MATRIX
FDA 510(k) clearance K930151 · decided 1993-09-23
Clearance details
- K-number
- K930151
- Device name
- OMNI-MATRIX
- Applicant
- Innovative Technology , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-12
- Decision date
- 1993-09-23
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- JEP
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ontario L3y 1j8, CA
- 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 |
|---|---|---|
| SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 (K091533) | Garrison Dental Solutions | 2009-08-17 |
| DOUBLE BOW TOOTH SEPARATOR (K831136) | Almore Intl., Inc. | 1983-06-08 |
Recalls involving this device
No recalls on record reference this clearance.