FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETCH AND BOND
K Number: K852660
·
Decision Jul 25, 1985
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
279
Review Days
31
Basic Information
- Device Name
- ETCH AND BOND
- K Number
- K852660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- DENTSPLY INTL.
- Date Received
- June 24, 1985
- Decision Date
- July 25, 1985
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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