Product code EBL
- Device name
- Pin, Retentive And Splinting, And Accessory Instruments
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3740
- 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 |
|---|---|---|---|
| K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. | 2000-11-09 |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | Dentauraum, Inc. | 1995-07-19 |
| K924376 | ROOT CANAL POST | The Thera Group | 1993-11-22 |
| K895283 | PROSTHETIC RESTORATION DEVICE | Swiss Precision Mfg. Corp. | 1990-02-14 |
| K895758 | PLASTIC TOOTH REINFORCEMENT KIT | Nanzee Dental Products | 1989-12-20 |
| K883074 | ELGILOY | Dale T. Dupuis | 1988-08-09 |
| K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. | 1986-10-14 |
| K844457 | SECURIPIN | Hughes Int'L, Inc. | 1984-12-27 |
| K830773 | MARKLEY THREADED WIRE | Almore Intl., Inc. | 1983-04-28 |
| K822412 | REINFORCING PIN | Filhol | 1982-08-30 |
| K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc. | 1976-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810060225295 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225288 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225271 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225264 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225257 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225240 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| 00810060225233 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2022-12-30 |
| D701CR8502 | Code Rings | PULPDENT CORPORATION | 2021-09-22 |
| D701CR82 | Code Rings | PULPDENT CORPORATION | 2021-09-22 |
| D701CR7502 | Code Rings | PULPDENT CORPORATION | 2021-09-22 |
| D701CR72 | Code Rings | PULPDENT CORPORATION | 2021-09-22 |
| 08800036206641 | Biotem | Biotem Co., ltd | 2018-06-09 |
| 08800036206634 | Biotem | Biotem Co., ltd | 2018-06-09 |
| 08800036206658 | Biotem | Biotem Co., ltd | 2018-06-09 |
| J011240010000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011200112000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011200114000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011200116000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011204217000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011204219000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011204221000 | N.A. | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240020000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240012000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240015000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240037000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240036000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240035000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240031000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240025000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |
| J011240022000 | rematitan® | DENTAURUM GmbH & Co.KG | 2016-09-15 |