ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
FDA 510(k) clearance K994203 · decided 2000-03-06
Clearance details
- K-number
- K994203
- Device name
- ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
- Applicant
- Bonart Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-13
- Decision date
- 2000-03-06
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hsingchang, Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.