Instruments, Dental Hand
Regulation 872.4565
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in DZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Den-Mat Corp. | 2 | 0 |
| Howmedica Corp. | 2 | 0 |
| Accor, Inc. | 1 | 0 |
| Alvin Meyer, D.D.S. | 1 | 0 |
| Centrix, Inc. | 1 | 0 |
| Dentsply Intl. | 1 | 0 |
| Fly Cast Technologies, Inc. | 1 | 0 |
| Healthco, Inc. | 1 | 0 |
| Ivoclar North America, Inc. | 1 | 0 |
| Kerrhawe SA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2012 | K111465 | COMPOTHIXO Kerrhawe SA | DZN |
| Aug 31, 2007 | K071858 | DENTAL MATRIX BAND Fly Cast Technologies, Inc. | DZN |
| Jun 22, 1990 | K901919 | CONTACT MOLAR BANDS AND CONTOUR STRIPS Ivoclar North America, Inc. | DZN |
| May 12, 1986 | K861581 | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) Centrix, Inc. | DZN |
| Dec 3, 1984 | K844324 | TIGER BAND World Wide Outdoor Marketing | DZN |
| Apr 13, 1984 | K840984 | INTERDENTAL WEDGES Healthco, Inc. | DZN |
| Aug 16, 1982 | K822094 | DENTAL MATRIX BAND Dentsply Intl. | DZN |
| Jun 14, 1982 | K821444 | COLORED WEDGE USED TO SEPARATE TEETH Moyco Industries, Inc. | DZN |
| Aug 7, 1980 | K801142 | PALODENT MATRICES & BITINE RINGS Alvin Meyer, D.D.S. | DZN |
| Jul 28, 1980 | K801530 | COREFORM MOLDS Sybron Corp. | DZN |
| Jan 17, 1980 | K790555 | HEMO-WEDGE Parker Laboratories, Inc. | DZN |
| May 21, 1979 | K790600 | HOWMEDICA STRIP CROWN Howmedica Corp. | DZN |
| May 21, 1979 | K790599 | RUWA MATRIX STRIPS Howmedica Corp. | DZN |
| May 17, 1979 | K790633 | ACCOR MATRIX Accor, Inc. | DZN |
| Jan 3, 1978 | K772316 | MATRIX STRIP, DEAD-SOFT Den-Mat Corp. | DZN |
| Jan 3, 1978 | K772314 | WEDGES, RETAINING, MATRIX Den-Mat Corp. | DZN |
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