FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAVO KEY LASER 1242
K Number: K983100
·
Decision Jan 27, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
20
Review Days
146
Basic Information
- Device Name
- KAVO KEY LASER 1242
- K Number
- K983100
- 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
- KAVO AMERICA
- Date Received
- September 3, 1998
- Decision Date
- January 27, 1999
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K063624 | KAVO EVEREST C-TEMP | Feb 8, 2007 | Substantially Equivalent |
| K051909 | DIAGNODENT | Oct 21, 2005 | Substantially Equivalent |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Aug 3, 2005 | Substantially Equivalent |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | Jan 31, 2005 | Substantially Equivalent |
| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | Jul 24, 2003 | Substantially Equivalent |
| K031868 | PROPHYPEARLS | Jul 9, 2003 | Substantially Equivalent |
| K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES | May 2, 2003 | Substantially Equivalent |
| K024214 | KAVO EVEREST TITANBLANK | Mar 12, 2003 | Substantially Equivalent |