Product code JEP
- Device name
- Retainer, Matrix
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091533 | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 | Garrison Dental Solutions | 2009-08-17 |
| K930151 | OMNI-MATRIX | Innovative Technology , Ltd. | 1993-09-23 |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Almore Intl., Inc. | 1983-06-08 |
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|---|---|---|---|
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| G149TBSB1420 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB1380 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| 10304040144074 | Henry Schein | HENRY SCHEIN, INC. | 2021-03-12 |
| 10304040144067 | Henry Schein | HENRY SCHEIN, INC. | 2021-03-12 |
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| 10304040142803 | Henry Schein | HENRY SCHEIN, INC. | 2021-03-12 |
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