510(k) K833056
- Device
- Universal Line-a-plate
- Applicant
- LAURENTIAN LABORATORIES
- 510(k) number
- K833056
- Product code
- EBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-27
- Date received
- 1983-09-07
- Regulation
- 872.3570
- Classification name
- Denture Repair Kit
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004765453
- 3004727093
- 9616088
- 2241860
- 3009888344
- 3028271666
- 1528710
- 3007329020
- 3015128224
- 1643817
- 1423537
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850927 | COMPLETE DENTURE REPAIR KIT | Tooth Aid Lab, Inc. | 1985-07-02 |
| K844480 | DENTAL ORAL CARE SYSTEMS & COMPONENTS | Advanced Bio Systems, Inc. | 1985-06-19 |
| K833057 | UNIVERSAL FIX-A-PLATE | Laurentian Laboratories | 1984-02-27 |
| K820245 | SAFE TDENT | Professional Dental Studios | 1982-04-09 |
| K820685 | DENTURE ADJUSTMENT KIT | Camdent Laboratories | 1982-04-09 |
| K770091 | EMERGENCY FAST-FIX DENTURE REPAIR KIT | Mr. Clarence Hurst | 1977-01-24 |