FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCU-MIX AMALGAMATOR
K Number: K910632
·
Decision Mar 15, 1991
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
14
Applicant Total
3
Review Days
30
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
- ACCU-MIX AMALGAMATOR
- K Number
- K910632
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Wykle Research, Inc.
- Date Received
- February 13, 1991
- Decision Date
- March 15, 1991
- Product Code
- EFD
- 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 |
|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFD), ordered by most recent decision date.
PENTAMIX 2
FDA 510(k)
FDA Class 1
·Dental
SILIMAT PLUS
FDA 510(k)
FDA Class 1
·Dental
IPT CAPSULE MIXER
FDA 510(k)
FDA Class 1
·Dental
AUTOMIX DENTAL AMALGAMATOR
FDA 510(k)
FDA Class 1
·Dental
DUOMAT 3 AMALGAMATOR
FDA 510(k)
FDA Class 1
·Dental
MIXOMAT AMALGAMATOR
FDA 510(k)
FDA Class 1
·Dental