FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K Number: K070663
·
Decision Jul 5, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
69
Review Days
118
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Basic Information
- Device Name
- A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
- K Number
- K070663
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A-Dec, Inc.
- Date Received
- March 9, 2007
- Decision Date
- July 5, 2007
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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|---|---|---|---|
| K213932 | A-dec 300, A-dec 500 | Mar 2, 2022 | Substantially Equivalent |
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| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | Aug 30, 2005 | Substantially Equivalent |
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| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | Dec 4, 2003 | Substantially Equivalent |