| Device Type ID | 1307 |
| Device Name | Varnish, Cavity |
| Regulation Description | Cavity Varnish. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.3260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LBH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1307 |
| Device | Varnish, Cavity |
| Product Code | LBH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cavity Varnish. |
| CFR Regulation Number | 872.3260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLGATE-PALMOLIVE CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IVOCLAR VIVADENT AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVA BIOMATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAC-DENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PREVENTIVE TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYLPHAR N.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YOUNG INNOVATIONS, I | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 31 |
Device Operates Differently Than Expected | 28 |
Extrusion | 25 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Patient-Device Incompatibility | 14 |
Labelling, Instructions For Use Or Training Problem | 8 |
Insufficient Information | 6 |
Expulsion | 5 |
Device Handling Problem | 2 |
Use Of Device Problem | 2 |
| Total Device Problems | 139 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Nov-02-2018 |
| 2 | Dharma Research, Inc. | II | Dec-01-2014 |
| 3 | Discus Dental LLC | II | Nov-24-2014 |
| 4 | Heraeus Kulzer, LLC. | II | May-23-2014 |
| 5 | Ultradent Products, Inc. | II | Jan-03-2019 |