FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISC NEEDLE SET #TX-8220
K Number: K823676
·
Decision Jan 9, 1983
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
3
Applicant Total
4
Review Days
33
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
- DISC NEEDLE SET #TX-8220
- K Number
- K823676
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Today'S Machining & Design, Inc.
- Date Received
- December 7, 1982
- Decision Date
- January 9, 1983
- Product Code
- EMI
- 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 |
|---|---|---|---|
| EMI | File, Bone, Surgical | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMI), ordered by most recent decision date.
MINI-MILL
FDA 510(k)
FDA Class 1
·Dental
PLANUSTAR AND DENS NOBILIS DENTURE TEETH
FDA 510(k)
FDA Class 1
·Dental
865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES
FDA 510(k)
FDA Class 1
·Dental