FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
MATCHMAKER/PROPAQUE PORCELAIN
K Number: K960770
·
Decision Nov 19, 1996
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
7
Review Days
267
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Basic Information
- Device Name
- MATCHMAKER/PROPAQUE PORCELAIN
- K Number
- K960770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Davis Schottlander & Davis, Ltd.
- Date Received
- February 26, 1996
- Decision Date
- November 19, 1996
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, 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 |
| K024250 | MATCH PRESS PRESSABLE CERAMIC | Aug 25, 2003 | 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 |