COMPOTHIXO
FDA 510(k) clearance K111465 · decided 2012-07-25
Clearance details
- K-number
- K111465
- Device name
- COMPOTHIXO
- Applicant
- Kerrhawe SA
- Decision
- Substantially Equivalent
- Date received
- 2011-05-26
- Decision date
- 2012-07-25
- Days to decision
- 426 days
- Clearance type
- Traditional
- Product code
- DZN
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, 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 |
|---|---|---|
| DENTAL MATRIX BAND (K071858) | Fly Cast Technologies, Inc. | 2007-08-31 |
| CONTACT MOLAR BANDS AND CONTOUR STRIPS (K901919) | Ivoclar North America, Inc. | 1990-06-22 |
| CENTRIX PCR MOLAR MATRIX FORMS (BANDS) (K861581) | Centrix, Inc. | 1986-05-12 |
| TIGER BAND (K844324) | World Wide Outdoor Marketing | 1984-12-03 |
| INTERDENTAL WEDGES (K840984) | Healthco, Inc. | 1984-04-13 |
| DENTAL MATRIX BAND (K822094) | Dentsply Intl. | 1982-08-16 |
| COLORED WEDGE USED TO SEPARATE TEETH (K821444) | Moyco Industries, Inc. | 1982-06-14 |
| PALODENT MATRICES & BITINE RINGS (K801142) | Alvin Meyer, D.D.S. | 1980-08-07 |
| COREFORM MOLDS (K801530) | Sybron Corp. | 1980-07-28 |
| HEMO-WEDGE (K790555) | Parker Laboratories, Inc. | 1980-01-17 |
| RUWA MATRIX STRIPS (K790599) | Howmedica Corp. | 1979-05-21 |
| HOWMEDICA STRIP CROWN (K790600) | Howmedica Corp. | 1979-05-21 |
Recalls involving this device
No recalls on record reference this clearance.