Product code EIK
- Device name
- Carver, Wax, Dental
- 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 |
|---|---|---|---|
| K013993 | NEOCALEX | Stephen M Koral, Dmd | 2002-02-22 |
| K972642 | PERIO CONTROL II | Estrad B.V. | 1998-01-26 |
| K902653 | PDS-2000 | Intl. Equipment and Supply Corp. | 1990-09-13 |
| K860817 | ROOT CANAL ORGANIZER | Pacific Union Dental, Inc. | 1986-03-17 |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Artiberia | 1985-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G149TBSB8080 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8090 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8100 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8110 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8120 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8140 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8150 | TBS BASICS | ACME ENTERPRISE. | 2026-05-18 |
| G149TBSB8060 | TBS BASICS | ACME ENTERPRISE. | 2026-05-17 |
| G149TBSB8070 | TBS BASICS | ACME ENTERPRISE. | 2026-05-17 |
| G149TBSB8160 | TBS BASICS | ACME ENTERPRISE. | 2026-05-17 |
| G149TBSB8170 | TBS BASICS | ACME ENTERPRISE. | 2026-05-17 |
| G149TBSB8050 | TBS BASICS | ACME ENTERPRISE. | 2026-05-17 |
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| 08800075627599 | OSUNG MND | OSUNG MND Co., Ltd. | 2025-11-03 |
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