| Device Type ID | 1285 |
| Device Name | Agent, Tooth Bonding, Resin |
| Regulation Description | Resin Tooth Bonding Agent. |
| 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 | 872.3200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KLE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1285 |
| Device | Agent, Tooth Bonding, Resin |
| Product Code | KLE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Resin Tooth Bonding Agent. |
| CFR Regulation Number | 872.3200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AMERICAN ORTHODONTICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
APEX DENTAL MATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BISCO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COLTENE HOLDING AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENMAT HOLDINGS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY INTERNATIONAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY TULSA DENTAL SPECIALTIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DHARMA RESEARCH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
E DENTAL PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IVOCLAR VIVADENT AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KERR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KURARAY NORITAKE DENTAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KURARAY NORITAKE DENTAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVA BIOMATERIALS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARKELL INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PREMIER DENTAL PRODUCTS CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHOFU DENTAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOKUYAMA DENTAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOCO GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 71 |
Appropriate Term/Code Not Available | 47 |
Adverse Event Without Identified Device Or Use Problem | 43 |
Patient-Device Incompatibility | 24 |
Improper Or Incorrect Procedure Or Method | 23 |
Use Of Device Problem | 10 |
Labelling, Instructions For Use Or Training Problem | 9 |
Device Handling Problem | 4 |
Missing Value Reason | 2 |
Insufficient Information | 1 |
Device Emits Odor | 1 |
Device Issue | 1 |
Leak / Splash | 1 |
Syringe | 1 |
Product Quality Problem | 1 |
Unexpected Therapeutic Results | 1 |
| Total Device Problems | 240 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cosmedent, Inc. | II | Feb-27-2018 |
| 2 | Novocol, Inc. | II | Jul-29-2014 |
| 3 | Voco GmbH | II | Jan-06-2017 |