FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DC ZIRKON
K Number: K001815
·
Decision Aug 10, 2000
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
10
Review Days
56
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Basic Information
- Device Name
- DC ZIRKON
- K Number
- K001815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Austenal, Inc.
- Date Received
- June 15, 2000
- Decision Date
- August 10, 2000
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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Other Clearances by Austenal, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011674 | DC - CRISTAL | Sep 4, 2001 | Substantially Equivalent |
| K001799 | DC-TELL | Aug 10, 2000 | Substantially Equivalent |
| K001798 | DC TITAN | Jul 31, 2000 | Substantially Equivalent |
| K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL | May 14, 1997 | Substantially Equivalent |
| K970205 | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY | Apr 21, 1997 | Substantially Equivalent |
| K955509 | MIDAS GOLD ELECTROFORMING SYSTEM | Dec 28, 1995 | Substantially Equivalent |
| K954810 | MYERSON IR DENTURE BASE | Nov 29, 1995 | Substantially Equivalent |
| K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL | Jan 5, 1994 | Substantially Equivalent |
| K924526 | DENTURE PLASTIC TEETH | Nov 4, 1992 | Substantially Equivalent |