FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
ODYSSEY I DENTAL WATER UNIT
K Number: K964796
·
Decision May 14, 1997
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
5
Review Days
166
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Basic Information
- Device Name
- ODYSSEY I DENTAL WATER UNIT
- K Number
- K964796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Germiphene Corp.
- Date Received
- November 29, 1996
- Decision Date
- May 14, 1997
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Germiphene Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | Dec 1, 1998 | Substantially Equivalent |
| K961289 | VAPOPHENE | Dec 4, 1997 | Substantially Equivalent |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | Nov 4, 1994 | Substantially Equivalent |
| K894933 | PERLIDENT | Oct 12, 1989 | Substantially Equivalent |