FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
K Number: K870230
·
Decision May 20, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
25
Review Days
119
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Basic Information
- Device Name
- ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
- K Number
- K870230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Degussa Dental, Inc.
- Date Received
- January 21, 1987
- Decision Date
- May 20, 1987
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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|---|---|---|---|
| K883758 | ALBABOND 60 | Oct 12, 1988 | Substantially Equivalent |
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| 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 |