FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPRESSION TUBE ADJUSTABLE
K Number: K833485
·
Decision Dec 26, 1983
Classifications
1
FEI Numbers
317
Registration Numbers
317
Same Product Code
15
Applicant Total
1
Review Days
80
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
- IMPRESSION TUBE ADJUSTABLE
- K Number
- K833485
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Zefr, Inc.
- Date Received
- October 7, 1983
- Decision Date
- December 26, 1983
- Product Code
- EHY
- 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 |
|---|---|---|---|
| EHY | Tray, Impression, Preformed | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHY), ordered by most recent decision date.
O-TRAY IMPRESSION TRAYS
FDA 510(k)
FDA Class 1
·Dental
EOS IMPRESSION TRAYS
FDA 510(k)
FDA Class 1
·Dental
OCCLUSAL HARMONY IMPRESSION TRAY
FDA 510(k)
FDA Class 1
·Dental
POST TRAY
FDA 510(k)
FDA Class 1
·Dental
PREFORMED DENTAL IMPRESSION TRAYS
FDA 510(k)
FDA Class 1
·Dental
CROWN INDEX TRAY
FDA 510(k)
FDA Class 1
·Dental