FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
K Number: K954790
·
Decision Jan 16, 1996
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
12
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
- K Number
- K954790
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4130
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tulsa Dental Products, Ltd.
- Date Received
- October 19, 1995
- Decision Date
- January 16, 1996
- Product Code
- DZA
- 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 |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | FDA class 1 | Dental |
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| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Apr 7, 1988 | Substantially Equivalent |