| Device Type ID | 1282 |
| Device Name | Resin, Root Canal Filling |
| Regulation Description | Root Canal Filling Resin. |
| 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 | 872.3820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KIF |
| 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 | 1282 |
| Device | Resin, Root Canal Filling |
| Product Code | KIF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Root Canal Filling Resin. |
| CFR Regulation Number | 872.3820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AVALON BIOMED INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMTA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY INTERNATIONAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY TULSA DENTAL SPECIALTIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVATIVE BIOCERAMIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ITENA CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MARUCHI | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MICRO-MEGA SOCIETE ANONYME | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVOCOL, INC., SEPTODONT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SONENDO, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
VERICOM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 11 |
Overfill | 9 |
Insufficient Information | 8 |
Appropriate Term/Code Not Available | 6 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Extrusion | 1 |
Component Missing | 1 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
| Total Device Problems | 42 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ormco/Sybronendo | II | Sep-16-2016 |