EBLClass I
Pin, Retentive And Splinting, And Accessory Instruments
21 CFR 872.3740 / Dental
EBL is the FDA product code for Pin, Retentive And Splinting, And Accessory Instruments, a class I device type, regulated under 21 CFR 872.3740. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- EBL
- Device name
- Pin, Retentive And Splinting, And Accessory Instruments
- Regulation
- 21 CFR 872.3740
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 1
Clearances, product code EBL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 2000 | 1 |
Applicants with the most clearances
Product code EBL| Applicant | Clearances |
|---|---|
| Almore Intl., Inc. | 1 |
| Cbs Intl. B.V. | 1 |
| Dale T. Dupuis | 1 |
| Dentauraum, Inc. | 1 |
| Filhol | 1 |
| Hughes Int'L, Inc. | 1 |
| Nanzee Dental Products | 1 |
| Parkell, Inc. | 1 |
| Swiss Precision Mfg. Corp. | 1 |
| The Thera Group | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abracadabra Implants Ltd.
- Accumedix, Inc.
- Angelus Industria de Productos Odontologicos
- Aspen Surgical Products, Inc.
- B. Ali Impex
- Biotem Co., Ltd.
- Blue Sky Bio, LLC
- Brasseler USA I, L.P.
- Bredent GmbH & Co.KG
- Cangzhou Lankang Medical Instruments Developing Co., Ltd.
- Changsha Nice Medical Instrument Limited Company
- CM Instrumente GmbH
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
