FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K Number: K001269
·
Decision Jun 21, 2000
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
1
Review Days
62
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
- DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
- K Number
- K001269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentalmatic Technologies, Inc.
- Date Received
- April 20, 2000
- Decision Date
- June 21, 2000
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJH), ordered by most recent decision date.
BEGOPAL+
FDA 510(k)
FDA Class 2
·Dental
CONTINUM V
FDA 510(k)
FDA Class 2
·Dental
CONTINUM
FDA 510(k)
FDA Class 2
·Dental
VERASOFT ES
FDA 510(k)
FDA Class 2
·Dental
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
FDA 510(k)
FDA Class 2
·Dental
WIROBOND C
FDA 510(k)
FDA Class 2
·Dental