EBOClass II
Denture Repair Kit
21 CFR 872.3570 / Dental
EBO is the FDA product code for Denture Repair Kit, a class II device type, regulated under 21 CFR 872.3570. FDA's definition for this code reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- EBO
- Device name
- Denture Repair Kit
- FDA definition
- This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation
- 21 CFR 872.3570
- Device class
- Class II
- Review panel
- Dental
- Submission type
- FDA code 7
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code EBO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1982 | 2 |
| 1984 | 2 |
| 1985 | 2 |
Applicants with the most clearances
Product code EBO| Applicant | Clearances |
|---|---|
| Laurentian Laboratories | 2 |
| Advanced Bio Systems, Inc. | 1 |
| Camdent Laboratories | 1 |
| Mr. Clarence Hurst | 1 |
| Professional Dental Studios | 1 |
| Tooth Aid Lab, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.