FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEGUDENT 14
K Number: K821446
·
Decision Jun 9, 1982
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
24
Review Days
26
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Basic Information
- Device Name
- DEGUDENT 14
- K Number
- K821446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- J. Aderer, Inc.
- Date Received
- May 14, 1982
- Decision Date
- June 9, 1982
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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FDA 510(k)
FDA Class 2
·Dental
Other Clearances by J. Aderer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822956 | G CAST | Oct 26, 1982 | Substantially Equivalent |
| K822957 | PURCAST | Oct 26, 1982 | Substantially Equivalent |
| K821798 | 82 ALLOY | Jul 13, 1982 | Substantially Equivalent |
| K821832 | DEGUCAST U | Jul 6, 1982 | Substantially Equivalent |
| K821572 | DUALLOR 'R' | Jun 14, 1982 | Substantially Equivalent |
| K821590 | PORS-ON | Jun 14, 1982 | Substantially Equivalent |
| K821407 | DEVA M | Jun 9, 1982 | Substantially Equivalent |
| K821521 | STABILOR NF | Jun 9, 1982 | Substantially Equivalent |
| K821613 | E.G. BRIDGE GOLD | Jun 4, 1982 | Substantially Equivalent |
| K821299 | CER-MATE | May 28, 1982 | Substantially Equivalent |