Product code DZP
- Device name
- Instrument, Diamond, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4535
- 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 |
|---|---|---|---|
| K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | 2012-04-20 |
| K943841 | SOPHOS DENTAL DIAMOND | Sophos Technologic | 1994-09-16 |
| K940908 | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. | 1994-08-29 |
| K934981 | DENTAL DRILL | Eare Consulting Service | 1994-02-03 |
| K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | 1993-03-16 |
| K913651 | MANI DIA-BURS | The Lahr Consulting Group, Inc. | 1992-01-14 |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. | 1990-07-13 |
| K901262 | F.G. LASER (DENTAL BUR) | Diamond Rotary and Carbide Intl. | 1990-07-09 |
| K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. | 1990-04-03 |
| K893844 | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. | 1989-08-11 |
| K885233 | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. | 1989-02-13 |
| K880179 | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. | 1988-03-09 |
| K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | 1987-05-18 |
| K854347 | HYBRID POINTS | Shofu Dental Corp. | 1985-12-27 |
| K833038 | SUMMA DISK | Shofu Dental Corp. | 1983-10-04 |
| K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Dental Corp. | 1983-10-04 |
| K832855 | TPE DIAMOND POINTS | Shofu Dental Corp. | 1983-09-29 |
| K802987 | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | 1980-12-30 |
| K802984 | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | 1980-12-30 |
| K780864 | DIAMOND STONES | Venture Technology, Inc. | 1978-06-14 |
| K760987 | DIAMOND STONES | Adp Intl., Inc. | 1976-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00887919317036 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029970 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029949 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029918 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029888 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029857 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029826 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029796 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029765 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029734 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029673 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029642 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029611 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029581 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029550 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029529 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029499 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029468 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 00887919227335 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535029703 | Brasseler USA Sterile Diamond | Peter Brasseler Holdings, LLC | 2026-05-27 |
| ESUN2943140145 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2943140125 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2943140105 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2433140185 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2433140165 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2433140145 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2433140125 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN2433140105 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN0053140185 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |
| ESUN0053140165 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-16 |