FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULSEMASTER ERBIUM DENTAL LASER SYSTEM
K Number: K012127
·
Decision Oct 4, 2001
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
87
Basic Information
- Device Name
- PULSEMASTER ERBIUM DENTAL LASER SYSTEM
- K Number
- K012127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMERICAN DENTAL TECHNOLOGIES, INC.
- Date Received
- July 9, 2001
- Decision Date
- October 4, 2001
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by AMERICAN DENTAL TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K023547 | DIOLASE 980 D LASER SYSTEM | Apr 15, 2003 | Substantially Equivalent |
| K012213 | GULLIVER AND CLASSE A | Aug 13, 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 |