FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
K Number: K100633
·
Decision Apr 1, 2010
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
51
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
- K Number
- K100633
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- D B Orthodontics, Ltd.
- Date Received
- March 5, 2010
- Decision Date
- April 1, 2010
- Product Code
- OAT
- 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 |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | FDA class 2 | Dental |
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Other Clearances by D B Orthodontics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | Oct 26, 2007 | Substantially Equivalent |