| Device Type ID | 1130 |
| Device Name | Activator, Ultraviolet, For Polymerization |
| Regulation Description | Ultraviolet Activator For Polymerization. |
| 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 | 872.6070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EBZ |
| 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 | 1130 |
| Device | Activator, Ultraviolet, For Polymerization |
| Product Code | EBZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultraviolet Activator For Polymerization. |
| CFR Regulation Number | 872.6070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAO GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTALL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTALL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTMATE TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EPIC MEDICAL CONCEPTS & INNOVATIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MONITEX INDUSTRIAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
NATIONAL DENTAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PREMIUM PLUS INTERNATIONAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROMIDENT LLC/ JOHNSON-PROMIDENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SATELEC-ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULTRADENT PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOCO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Output Problem | 6 |
Device Operates Differently Than Expected | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Device Issue | 1 |
Environmental Compatibility Problem | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 17 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Handpiece Headquarters | II | Feb-04-2019 |
| 2 | Ivoclar Vivadent, Inc. | II | Jun-09-2014 |