FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DC - CRISTAL
K Number: K011674
·
Decision Sep 4, 2001
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
10
Review Days
97
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Basic Information
- Device Name
- DC - CRISTAL
- K Number
- K011674
- 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
- May 30, 2001
- Decision Date
- September 4, 2001
- 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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| 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 |