EBO — Denture Repair Kit Class II
Classification Details
- Product Code
- EBO
- Device Class
- Class II
- Regulation Number
- 872.3570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K850927 | tooth aid lab | COMPLETE DENTURE REPAIR KIT | July 2, 1985 |
| K844480 | advanced bio systems | DENTAL ORAL CARE SYSTEMS & COMPONENTS | June 19, 1985 |
| K833056 | laurentian laboratories | UNIVERSAL LINE-A-PLATE | February 27, 1984 |
| K833057 | laurentian laboratories | UNIVERSAL FIX-A-PLATE | February 27, 1984 |
| K820245 | professional dental studios | SAFE TDENT | April 9, 1982 |
| K820685 | camdent laboratories | DENTURE ADJUSTMENT KIT | April 9, 1982 |
| K770091 | clarence hurst | EMERGENCY FAST-FIX DENTURE REPAIR KIT | January 24, 1977 |