FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
K Number: K081237
·
Decision Aug 25, 2008
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
1
Review Days
116
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
- K Number
- K081237
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Craftmaster Contour Equipment, Inc.
- Date Received
- May 1, 2008
- Decision Date
- August 25, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIA), ordered by most recent decision date.
Midmark Dental Delivery System
FDA 510(k)
FDA Class 1
·Dental
K5 Cart, K5 Mount, K5 Swing
FDA 510(k)
FDA Class 1
·Dental
Integral Dental Unit
FDA 510(k)
FDA Class 1
·Dental
Integral Dental Units
FDA 510(k)
FDA Class 1
·Dental
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
FDA 510(k)
FDA Class 1
·Dental
BDC Dental Unit
FDA 510(k)
FDA Class 1
·Dental