FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESTILUX UV SYSTEM
K Number: K770113
·
Decision Jan 28, 1977
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
25
Review Days
9
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Basic Information
- Device Name
- ESTILUX UV SYSTEM
- K Number
- K770113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Degussa Dental, Inc.
- Date Received
- January 19, 1977
- Decision Date
- January 28, 1977
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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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 |
| K880033 | DEGUSTAR | Mar 7, 1988 | Substantially Equivalent |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Jun 5, 1987 | Substantially Equivalent |