SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
FDA 510(k) clearance K091533 · decided 2009-08-17
Clearance details
- K-number
- K091533
- Device name
- SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
- Applicant
- Garrison Dental Solutions
- Decision
- Substantially Equivalent
- Date received
- 2009-05-26
- Decision date
- 2009-08-17
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JEP
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Shelton, CT, 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 |
|---|---|---|
| OMNI-MATRIX (K930151) | Innovative Technology , Ltd. | 1993-09-23 |
| DOUBLE BOW TOOTH SEPARATOR (K831136) | Almore Intl., Inc. | 1983-06-08 |
Recalls involving this device
No recalls on record reference this clearance.