FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMAPREP PLUS OVEN
K Number: K970134
·
Decision Mar 21, 1997
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
8
Review Days
65
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Basic Information
- Device Name
- THERMAPREP PLUS OVEN
- K Number
- K970134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tulsa Dental Products, Ltd.
- Date Received
- January 15, 1997
- Decision Date
- March 21, 1997
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
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|---|---|---|---|
| K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | Feb 10, 1997 | Substantially Equivalent |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Jan 16, 1996 | Substantially Equivalent |
| K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | May 26, 1994 | Substantially Equivalent |
| K933582 | PROFILE SERIES 29 FILES | Oct 20, 1993 | Substantially Equivalent |
| K910224 | THERMAPREP | Mar 29, 1991 | Substantially Equivalent |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Nov 13, 1990 | Substantially Equivalent |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Apr 7, 1988 | Substantially Equivalent |