FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-DEC 200 DENTAL SYSTEM
K Number: K102234
·
Decision Nov 24, 2010
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
69
Review Days
107
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Basic Information
- Device Name
- A-DEC 200 DENTAL SYSTEM
- K Number
- K102234
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A-Dec, Inc.
- Date Received
- August 9, 2010
- Decision Date
- November 24, 2010
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | Aug 30, 2005 | Substantially Equivalent |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | Dec 10, 2003 | Substantially Equivalent |
| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | Dec 4, 2003 | Substantially Equivalent |