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 |
|---|---|---|---|
| 10860013564701 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564718 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564725 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564732 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564756 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564763 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 10860013564770 | Curva | Gc Orthodontics America Inc. | 2026-05-28 |
| 07908611211255 | CURVERD SCISSORS FOR ALIGNERS | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07908611211187 | CERAMIC NANO TUBE TWEEZER | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 07898488905190 | INSTRUMENT FOR ICERAM SLB BRACKET | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| ESAM13309101 | STOMA® | Storz am Mark GmbH | 2025-04-30 |
| 00842092112588 | Stick® | Preat Corporation | 2022-10-24 |
| ESAM14613001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14612001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13376021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13375031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13375011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13371401 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13307001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12247201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12246201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12244201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12243201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12242201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12241201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12231001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12225001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12223001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12221001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12216001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |