FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANSWER DENTAL IMPLEMENT, EXPLORER
K Number: K894896
·
Decision Oct 30, 1989
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- ANSWER DENTAL IMPLEMENT, EXPLORER
- K Number
- K894896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Tern Chien Ent. Co., Ltd.
- Date Received
- August 1, 1989
- Decision Date
- October 30, 1989
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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