CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
FDA 510(k) clearance K861581 · decided 1986-05-12
Clearance details
- K-number
- K861581
- Device name
- CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
- Applicant
- Centrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-29
- Decision date
- 1986-05-12
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DZN
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Stratford, 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 |
|---|---|---|
| COMPOTHIXO (K111465) | Kerrhawe SA | 2012-07-25 |
| 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 |
| 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.