FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
K Number: K102241
·
Decision Mar 23, 2011
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
6
Review Days
226
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Basic Information
- Device Name
- ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
- K Number
- K102241
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anthogyr Sas
- Date Received
- August 9, 2010
- Decision Date
- March 23, 2011
- Product Code
- EBW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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Other Clearances by Anthogyr Sas
| K Number | Device Name | ||
|---|---|---|---|
| K161177 | Axiom PX | Jun 15, 2017 | Substantially Equivalent |
| K141450 | AXIOM 2.8 | Sep 17, 2014 | Substantially Equivalent |
| K131066 | AXIOM REG | Feb 21, 2014 | Substantially Equivalent |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Oct 7, 2011 | Substantially Equivalent |
| K101913 | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM | Mar 11, 2011 | Substantially Equivalent |