GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
FDA 510(k) clearance K983183 · decided 1998-12-10
Clearance details
- K-number
- K983183
- Device name
- GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
- Applicant
- Bien Air USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-11
- Decision date
- 1998-12-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Irvine, CA, US
- 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.