FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIER MIRROR WARMER
K Number: K945395
·
Decision Jan 18, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
31
Applicant Total
41
Review Days
76
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Basic Information
- Device Name
- PREMIER MIRROR WARMER
- K Number
- K945395
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Premier Dental Products Co.
- Date Received
- November 3, 1994
- Decision Date
- January 18, 1995
- Product Code
- ETF
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | FDA class 1 | Ear, Nose, Throat |
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| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Oct 4, 2006 | Substantially Equivalent |
| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Sep 21, 2004 | Substantially Equivalent |