FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROFILE SERIES 29 FILES
K Number: K933582
·
Decision Oct 20, 1993
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- PROFILE SERIES 29 FILES
- K Number
- K933582
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tulsa Dental Products, Ltd.
- Date Received
- July 23, 1993
- Decision Date
- October 20, 1993
- Product Code
- EKS
- 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 |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | FDA class 1 | Dental |
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Other Clearances by Tulsa Dental Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K970134 | THERMAPREP PLUS OVEN | Mar 21, 1997 | Substantially Equivalent |
| 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 |
| 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 |