FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEGUSTAR
K Number: K880033
·
Decision Mar 7, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
25
Review Days
62
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Basic Information
- Device Name
- DEGUSTAR
- K Number
- K880033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Degussa Dental, Inc.
- Date Received
- January 5, 1988
- Decision Date
- March 7, 1988
- 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 Degussa Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883758 | ALBABOND 60 | Oct 12, 1988 | Substantially Equivalent |
| K883511 | ALBABOND E | Oct 6, 1988 | Substantially Equivalent |
| K883508 | HERA H | Sep 22, 1988 | Substantially Equivalent |
| K883509 | HERAEUS DG 63 | Sep 22, 1988 | Substantially Equivalent |
| K883510 | DEGUPAL 4 | Sep 15, 1988 | Substantially Equivalent |
| K883507 | HERAEUS C SPECIAL | Sep 15, 1988 | Substantially Equivalent |
| K883512 | HERAEUS WHITE | Sep 6, 1988 | Substantially Equivalent |
| K883036 | PALLIAG NF III | Aug 12, 1988 | Substantially Equivalent |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Jun 5, 1987 | Substantially Equivalent |
| K870230 | ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 | May 20, 1987 | Substantially Equivalent |