FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFECT CHOICE
K Number: K884245
·
Decision Jan 4, 1989
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
4
Review Days
85
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
- PERFECT CHOICE
- K Number
- K884245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Challenge Products, Inc.
- Date Received
- October 11, 1988
- Decision Date
- January 4, 1989
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJK), ordered by most recent decision date.
Bright Cavity Liner
FDA 510(k)
FDA Class 2
·Dental
3M VitCal Liner/Base
FDA 510(k)
FDA Class 2
·Dental
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
FDA 510(k)
FDA Class 2
·Dental
CleaniCal
FDA 510(k)
FDA Class 2
·Dental
LC ResinCal PC
FDA 510(k)
FDA Class 2
·Dental
Parkell Desensitizer Gel
FDA 510(k)
FDA Class 2
·Dental