FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMAPOST ENDODONTIC ROOT CANAL POST
K Number: K922931
·
Decision May 26, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
8
Review Days
708
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Basic Information
- Device Name
- THERMAPOST ENDODONTIC ROOT CANAL POST
- K Number
- K922931
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tulsa Dental Products, Ltd.
- Date Received
- June 17, 1992
- Decision Date
- May 26, 1994
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
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| 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 |