FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GULLIVER AND CLASSE A
K Number: K012213
·
Decision Aug 13, 2001
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- GULLIVER AND CLASSE A
- K Number
- K012213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Dental Technologies, Inc.
- Date Received
- July 16, 2001
- Decision Date
- August 13, 2001
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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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|---|---|---|---|
| K023547 | DIOLASE 980 D LASER SYSTEM | Apr 15, 2003 | Substantially Equivalent |
| K012127 | PULSEMASTER ERBIUM DENTAL LASER SYSTEM | Oct 4, 2001 | Substantially Equivalent |
| K984486 | PULSEMASTER DENTAL LASER SYSTEM | May 13, 1999 | Substantially Equivalent |
| K972325 | PULSEMASTER 1000 ST DENTAL LASER SYSTEM | Sep 19, 1997 | Substantially Equivalent |
| K961269 | PULSEMASTER | Mar 10, 1997 | Substantially Equivalent |
| K961136 | PULSEMASTER | Jun 3, 1996 | Substantially Equivalent |
| K952333 | PLASMA ARC CURING SYSTEM | Aug 10, 1995 | Substantially Equivalent |