Product code DZN
- Device name
- Instruments, Dental Hand
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111465 | COMPOTHIXO | Kerrhawe SA | 2012-07-25 |
| K071858 | DENTAL MATRIX BAND | Fly Cast Technologies, Inc. | 2007-08-31 |
| K901919 | CONTACT MOLAR BANDS AND CONTOUR STRIPS | Ivoclar North America, Inc. | 1990-06-22 |
| K861581 | CENTRIX PCR MOLAR MATRIX FORMS (BANDS) | Centrix, Inc. | 1986-05-12 |
| K844324 | TIGER BAND | World Wide Outdoor Marketing | 1984-12-03 |
| K840984 | INTERDENTAL WEDGES | Healthco, Inc. | 1984-04-13 |
| K822094 | DENTAL MATRIX BAND | Dentsply Intl. | 1982-08-16 |
| K821444 | COLORED WEDGE USED TO SEPARATE TEETH | Moyco Industries, Inc. | 1982-06-14 |
| K801142 | PALODENT MATRICES & BITINE RINGS | Alvin Meyer, D.D.S. | 1980-08-07 |
| K801530 | COREFORM MOLDS | Sybron Corp. | 1980-07-28 |
| K790555 | HEMO-WEDGE | Parker Laboratories, Inc. | 1980-01-17 |
| K790599 | RUWA MATRIX STRIPS | Howmedica Corp. | 1979-05-21 |
| K790600 | HOWMEDICA STRIP CROWN | Howmedica Corp. | 1979-05-21 |
| K790633 | ACCOR MATRIX | Accor, Inc. | 1979-05-17 |
| K772314 | WEDGES, RETAINING, MATRIX | Den-Mat Corp. | 1978-01-03 |
| K772316 | MATRIX STRIP, DEAD-SOFT | Den-Mat Corp. | 1978-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06954454001707 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015988 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015971 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015353 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015346 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015339 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015322 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454015315 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001745 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001738 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001721 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001714 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001691 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001684 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454001509 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000113 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000106 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000090 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000083 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000076 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000069 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-28 |
| 06954454000052 | COTISEN | Huanghua Promisee Dental Co., Ltd. | 2026-10-27 |
| 00083208130380 | Scissors Dean T/C Curved | Suncoast Dental, Inc | 2026-10-07 |
| 00816594025462 | CONTACT MATRIX SYSTEM | Zest Anchors, LLC | 2026-10-01 |
| 00816594025448 | CONTACT MATRIX SYSTEM | Zest Anchors, LLC | 2026-10-01 |
| 00816594025714 | CONTACT MATRIX SYSTEM | Zest Anchors, LLC | 2026-10-01 |
| 00348783008722 | Premier Applicators | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-01 |
| 07895742289348 | Morelli | Dental Morelli Ltda | 2024-09-09 |
| 07895742283162 | Morelli | Dental Morelli Ltda | 2023-06-06 |
| 07895742180140 | Morelli | Dental Morelli Ltda | 2021-04-30 |