FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
K Number: K963548
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
3
Review Days
139
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Basic Information
- Device Name
- DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
- K Number
- K963548
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mrlb Intl., Inc.
- Date Received
- September 5, 1996
- Decision Date
- January 22, 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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