Product code DZM
- Device name
- Needle, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4730
- 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 |
|---|---|---|---|
| K990511 | X-TIP INTRAOSSEOUS PERFORATOR | Schiff & Co. | 1999-04-27 |
| K920758 | JENKER NEEDLE STICK PROTECTOR | Dentsply Intl. | 1992-04-28 |
| K914562 | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | Aseptic Dental Technologies, Inc. | 1992-03-09 |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Specialites Septodont | 1991-11-07 |
| K910475 | DENTAL NEEDLE PROTECTIVE SYSTEM | Health Technology Systems, Inc. | 1991-09-13 |
| K910446 | STABIDENT LOCAL ANESTHESIA SYSTEM | Fairfax Dental, Inc. | 1991-06-03 |
| K896219 | SAFE-T-CAP NEEDLE COVER | Ausmedics Pty , Ltd. | 1990-01-22 |
| K894373 | NIPRO DENTAL NEEDLE | Pharma-Plast USA, Inc. | 1989-10-13 |
| K870921 | DENTAL NEEDLE (CARTRIDGE TYPE) | Churchill Corp. | 1987-04-03 |
| K864970 | TERUMO DENTAL NEEDLES | Terumo Medical Corp. | 1987-03-10 |
| K861150 | EXEL DENTAL NEEDLE | Exel Intl. | 1986-04-11 |
| K851524 | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | Specialites Septodont | 1985-09-23 |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Smith & Nephew, Mpl Division | 1984-03-30 |
| K820568 | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. | 1982-04-09 |
| K802811 | MONOJECT ROOT CANAL FILLING MAT. NEEDLE | Sherwood Medical Co. | 1980-11-24 |
| K761206 | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division | 1976-12-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D832BLT100501 | Plasdent | PLASDENT CORPORATION | 2026-05-28 |
| D1250802 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1250812 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1250822 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D125YS10012 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D125YS10022 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D125YS10072 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D125YS10122 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| G001HSB1071101 | House Brand Dentistry | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | 2024-06-05 |
| 08053610771633 | FAIRFAX DENTAL | TECNOFAR SPA | 2023-07-24 |
| 08053610771626 | FAIRFAX DENTAL | TECNOFAR SPA | 2023-07-24 |
| 08053610771619 | FAIRFAX DENTAL | TECNOFAR SPA | 2023-07-24 |
| 08053610771862 | ORABLOC | TECNOFAR SPA | 2023-06-22 |
| 08053610771855 | ORABLOC | TECNOFAR SPA | 2023-06-22 |
| 08053610771848 | ORABLOC | TECNOFAR SPA | 2023-06-22 |
| ETDG1665852 | NA | medmix Deutschland GmbH | 2023-01-26 |
| ETDG1665862 | NA | medmix Deutschland GmbH | 2023-01-26 |
| ETDG1665842 | NA | medmix Deutschland GmbH | 2023-01-26 |
| ETDG1622422 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1622412 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1622402 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1622392 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1622382 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1622372 | Painless Steel ® | medmix Deutschland GmbH | 2022-12-12 |
| ETDG1827612 | NA | medmix Deutschland GmbH | 2022-12-09 |
| ETDG1827622 | NA | medmix Deutschland GmbH | 2022-12-09 |
| ETDG1827632 | NA | medmix Deutschland GmbH | 2022-12-09 |
| ETDG1827642 | NA | medmix Deutschland GmbH | 2022-12-09 |
| ETDG1827652 | NA | medmix Deutschland GmbH | 2022-12-09 |
| ETDG1827662 | NA | medmix Deutschland GmbH | 2022-12-09 |