Product code ELA
- Device name
- Instrument, Hand, Calculus Removal
- 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 |
|---|---|---|---|
| K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | Ela Medical, Inc. | 1995-08-15 |
| K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | Travenol Laboratories, S.A. | 1986-03-13 |
| K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | Miltex, Inc. | 1982-11-24 |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Analytic Technology | 1980-11-12 |
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| 00810132809453 | House Brand Dentistry | Frontier Dental Supply Inc | 2025-05-14 |
| 00810132809460 | House Brand Dentistry | Frontier Dental Supply Inc | 2025-05-14 |
| 00047701001813 | Dentek | DenTek Oral Care, Inc. | 2024-06-19 |
| ESAM1825001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM1826001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM1820001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
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