FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
K Number: K962543
·
Decision Sep 11, 1996
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
13
Review Days
75
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
- ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
- K Number
- K962543
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nsk Nakanishi, Inc.
- Date Received
- June 28, 1996
- Decision Date
- September 11, 1996
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFB), ordered by most recent decision date.
High speed air turbine handpiece
FDA 510(k)
FDA Class 1
·Dental
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
FDA 510(k)
FDA Class 1
·Dental
Synea Fusion Handpieces (Intensiv & Profin)
FDA 510(k)
FDA Class 1
·Dental
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
FDA 510(k)
FDA Class 1
·Dental
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
FDA 510(k)
FDA Class 1
·Dental
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Nsk Nakanishi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | Aug 10, 1999 | Substantially Equivalent |
| K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | Jun 23, 1999 | Substantially Equivalent |
| K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Jun 9, 1999 | Substantially Equivalent |
| K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Mar 24, 1999 | Substantially Equivalent |
| K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Mar 19, 1999 | Substantially Equivalent |
| K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | Jun 5, 1998 | Substantially Equivalent |
| K972924 | SURGIC II IMPLANT CONTROL UNIT | Oct 30, 1997 | Substantially Equivalent |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Oct 8, 1997 | Substantially Equivalent |
| K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Jun 20, 1997 | Substantially Equivalent |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Apr 15, 1997 | Substantially Equivalent |