FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
J. MORITA FLEX M-3 TORX HARDPIECE
K Number: K821739
·
Decision Jun 25, 1982
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
22
Review Days
11
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
- J. MORITA FLEX M-3 TORX HARDPIECE
- K Number
- K821739
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Pacific Dental Corp.
- Date Received
- June 14, 1982
- Decision Date
- June 25, 1982
- Product Code
- EKX
- 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKX), ordered by most recent decision date.
Alpha Endo Handpiece (Alpha Endo)
FDA 510(k)
FDA Class 1
·Dental
InnerView System
FDA 510(k)
FDA Class 1
·Dental
EnDrive (EnDriveUS)
FDA 510(k)
FDA Class 1
·Dental
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
FDA 510(k)
FDA Class 1
·Dental
ChecQ (AC100)
FDA 510(k)
FDA Class 1
·Dental
HPR Cordless Hygiene Handpiece
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Pacific Dental Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K821782 | BEACH ANESTHETIC SYRINGE CARTR. TYPE | Jul 20, 1982 | Substantially Equivalent |
| K821783 | BEACH SILICATE FILLING & LINING APPLIC. | Jul 6, 1982 | Substantially Equivalent |
| K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | Jul 6, 1982 | Substantially Equivalent |
| K821789 | BEACH CURETTE NO. 2 AND NO. 3 T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Jul 6, 1982 | Substantially Equivalent |
| K821777 | BEACH MOUTH MIRROR | Jul 6, 1982 | Substantially Equivalent |
| K821780 | BEACH EXPLORER NO. 23T.G. | Jul 6, 1982 | Substantially Equivalent |
| K821785 | BEACH AMALGAM CARVER | Jul 6, 1982 | Substantially Equivalent |
| K821779 | BEACH AMALGAM CARRIER, GUN TYPE | Jul 6, 1982 | Substantially Equivalent |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | Jul 6, 1982 | Substantially Equivalent |