FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MATCH PRESS PRESSABLE CERAMIC
K Number: K024250
·
Decision Aug 25, 2003
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
7
Review Days
245
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Basic Information
- Device Name
- MATCH PRESS PRESSABLE CERAMIC
- K Number
- K024250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Davis Schottlander & Davis, Ltd.
- Date Received
- December 23, 2002
- Decision Date
- August 25, 2003
- 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 Davis Schottlander & Davis, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K024252 | MATCH MASTER LOW FUSION PORCELAIN | Jan 22, 2004 | Substantially Equivalent |
| K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | Jun 16, 2000 | Substantially Equivalent |
| K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL | Dec 22, 1999 | Substantially Equivalent |
| K984134 | NATURA DENTURE TEETH | Feb 12, 1999 | Substantially Equivalent |
| K984128 | ENIGMA DENTURE TEETH | Feb 9, 1999 | Substantially Equivalent |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | Nov 19, 1996 | Substantially Equivalent |