FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRAMATE 990
K Number: K781114
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
12
Review Days
42
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
- ULTRAMATE 990
- K Number
- K781114
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Litton Dental Products
- Date Received
- July 3, 1978
- Decision Date
- August 14, 1978
- 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
Other Clearances by Litton Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K791704 | MASTERSCALE II | Oct 26, 1979 | Substantially Equivalent |
| K791024 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | Sep 17, 1979 | Substantially Equivalent |
| K781044 | ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM | Jun 30, 1978 | Substantially Equivalent |
| K772244 | ILLUMINATED DENTAL HANDPIECE | Jan 20, 1978 | Substantially Equivalent |
| K771556 | EXR | Aug 22, 1977 | Substantially Equivalent |
| K771557 | ULTRASON 990 | Aug 19, 1977 | Substantially Equivalent |
| K771251 | HU:500, HYGIENASSIST | Jul 15, 1977 | Substantially Equivalent |
| K771252 | CB600, TURBINE CONTROL BOL | Jul 15, 1977 | Substantially Equivalent |
| K761246 | SONUS III | Dec 16, 1976 | Substantially Equivalent |
| K761247 | LT:200, LOVING TOUCH | Dec 16, 1976 | Substantially Equivalent |