FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)
K Number: K892710
·
Decision Oct 24, 1989
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
4
Review Days
193
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Basic Information
- Device Name
- ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)
- K Number
- K892710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Prometex, Inc.
- Date Received
- April 14, 1989
- Decision Date
- October 24, 1989
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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