FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROPHYPEARLS
K Number: K031868
·
Decision Jul 9, 2003
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
20
Review Days
22
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Basic Information
- Device Name
- PROPHYPEARLS
- K Number
- K031868
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kavo America
- Date Received
- June 17, 2003
- Decision Date
- July 9, 2003
- 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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Other Clearances by Kavo America
| K Number | Device Name | ||
|---|---|---|---|
| K073074 | KEY LASER III 1243 US WITH DETECT | Jul 10, 2008 | Substantially Equivalent |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | Oct 26, 2007 | Substantially Equivalent |
| 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 |
| 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 |
| K012308 | KAVO QUATTROCARE | Jun 26, 2002 | Substantially Equivalent |