Product code EHA
- Device name
- Aligner, Beam, X-Ray
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.1820
- 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 |
|---|---|---|---|
| K891186 | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT | Benn Research , Ltd. | 1989-04-12 |
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| D003B01220001 | Schick | Dentsply International Inc. | 2024-11-06 |
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