FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K Number: K874500
·
Decision Feb 18, 1988
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
45
Review Days
108
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Basic Information
- Device Name
- GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
- K Number
- K874500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Harry J. Bosworth Co.
- Date Received
- November 2, 1987
- Decision Date
- February 18, 1988
- 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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| K040547 | AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE | Mar 19, 2004 | Substantially Equivalent |
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| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Sep 4, 2003 | Substantially Equivalent |