| Device Type ID | 1180 |
| Device Name | Unit, Operative Dental |
| Regulation Description | Dental Operative Unit And Accessories. |
| 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 | 872.6640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EIA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1180 |
| Device | Unit, Operative Dental |
| Product Code | EIA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Operative Unit And Accessories. |
| CFR Regulation Number | 872.6640 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEFLA S.C. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANAHER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ERGONOMIC PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOREST DENTAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEKA DENTAL A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KALTENBACH & VOIGT GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KAVO DENTAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PRO DENTAL SERVICES LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RITTER CONCEPT GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAKARA BELMONT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THEROZONE USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Markings / Labelling Problem | 98 |
Overheating Of Device | 98 |
Device Displays Incorrect Message | 71 |
Positioning Problem | 51 |
Unintended Power Up | 47 |
Device Remains Activated | 40 |
Disassembly | 30 |
Detachment Of Device Or Device Component | 11 |
Break | 10 |
Leak / Splash | 10 |
Unintended Movement | 9 |
Cut In Material | 7 |
Smoking | 6 |
Electrical /Electronic Property Problem | 5 |
Fluid Leak | 5 |
Mechanical Problem | 4 |
Metal Shedding Debris | 3 |
Device Operates Differently Than Expected | 3 |
Unstable | 2 |
Misconnection | 1 |
Migration Or Expulsion Of Device | 1 |
Unintended Ejection | 1 |
Retraction Problem | 1 |
Misassembled | 1 |
Electrical Power Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
No Device Output | 1 |
Component Falling | 1 |
Device Unsafe To Use In Environment | 1 |
Peeled / Delaminated | 1 |
Material Fragmentation | 1 |
Device Issue | 1 |
| Total Device Problems | 523 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Danville Materials, Inc. | II | Aug-12-2016 |
| 2 | William C. Domb, D.M.D., A Professional Corporation | II | May-09-2014 |