FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K Number: K982009
·
Decision Jun 25, 1998
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
281
Applicant Total
4
Review Days
84
Basic Information
- Device Name
- ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
- K Number
- K982009
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SCITECH SOLUTIONS, INC.
- Date Received
- April 2, 1998
- Decision Date
- June 25, 1998
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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