| Device Type ID | 1249 |
| Device Name | Material, Impression |
| Regulation Description | Impression Material. |
| 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 | 872.3660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ELW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1249 |
| Device | Material, Impression |
| Product Code | ELW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Impression Material. |
| CFR Regulation Number | 872.3660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAVEX HOLLAND B.V | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DREVE DENTAMID GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HRS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HYGEDENT INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HYGEDENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IVOCLAR VIVADENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
META BIOMED, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MILLENNIUM COMPANY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM GERMANY GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM IMPLANT CO LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM IMPLANT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAC-DENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RIZHAO HUGE DENTAL INDUSTRY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPIDENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 35 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Appropriate Term/Code Not Available | 5 |
Use Of Device Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Appears To Trigger Rejection | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Difficult To Remove | 1 |
Obstruction Of Flow | 1 |
Complete Blockage | 1 |
Off-Label Use | 1 |
Material Too Rigid Or Stiff | 1 |
Device Handling Problem | 1 |
Entrapment Of Device | 1 |
Torn Material | 1 |
| Total Device Problems | 78 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ivoclar Vivadent, Inc. | II | Dec-07-2016 |