DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
FDA 510(k) clearance K101717 · decided 2010-08-20
Clearance details
- K-number
- K101717
- Device name
- DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
- Applicant
- Aerobine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-18
- Decision date
- 2010-08-20
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Diego, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.