FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUAPLAST PALATAL STENT
K Number: K973370
·
Decision Dec 2, 1997
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
8
Review Days
85
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Basic Information
- Device Name
- AQUAPLAST PALATAL STENT
- K Number
- K973370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wfr/Aquaplast Corp.
- Date Received
- September 8, 1997
- Decision Date
- December 2, 1997
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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|---|---|---|---|
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| K943871 | AQUAPLAST TIE DOWN DRESSING | Sep 30, 1994 | Substantially Equivalent |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | Jul 29, 1994 | Substantially Equivalent |
| K935067 | AQUAPLAST | May 26, 1994 | Substantially Equivalent |