FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOBOND MASTER STAIN AND GLAZE KIT
K Number: K771179
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
38
Applicant Total
279
Review Days
15
Basic Information
- Device Name
- BIOBOND MASTER STAIN AND GLAZE KIT
- K Number
- K771179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- June 30, 1977
- Decision Date
- July 15, 1977
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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