FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SUREFLEX FILES AND INSTRUMENTS
K Number: K971603
·
Decision Jun 4, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
24
Applicant Total
279
Review Days
34
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Basic Information
- Device Name
- STERILE SUREFLEX FILES AND INSTRUMENTS
- K Number
- K971603
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Intl.
- Date Received
- May 1, 1997
- Decision Date
- June 4, 1997
- Product Code
- EFA
- 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 |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | FDA class 1 | Dental |
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