FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE WAND
K Number: K961648
·
Decision Jul 5, 1996
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
10
Review Days
67
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Basic Information
- Device Name
- THE WAND
- K Number
- K961648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spintech, Inc.
- Date Received
- April 29, 1996
- Decision Date
- July 5, 1996
- Product Code
- EJI
- 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 |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
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Other Clearances by Spintech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223079 | Stage | Oct 28, 2022 | Substantially Equivalent |
| K210843 | STAGE | Jun 29, 2021 | Substantially Equivalent |
| K173224 | SPIN-SWI | Feb 23, 2018 | Substantially Equivalent |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Sep 2, 2003 | Substantially Equivalent |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | Jun 29, 2001 | Substantially Equivalent |
| K992404 | THE WAND | Jun 6, 2000 | Substantially Equivalent |
| K992819 | WAND PLUS | May 11, 2000 | Substantially Equivalent |
| K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE | Feb 8, 1996 | Substantially Equivalent |
| K922238 | LEAPLAZA FRAME | Dec 23, 1992 | Substantially Equivalent |