The Wand
510(k) K961648
The Wand is a Class II device made by Spintech, Inc., cleared under FDA 510(k) K961648 on 5 Jul 1996, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961648 | Date5 Jul 1996 | StatusActive |
Official records
- FDA 510(k) database K961648
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EJI
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K961648
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| the Wand Handpiece WA-2050-2725 | WA-2050-2725 | 20618874000114 | — | On the market |
| the Wand Handpiece WA-2050-2725 | WA-2050-2725 | 10618874000117 | — | On the market |
| the Wand Handpiece WA-2050-301 | WA-2050-301 | 10618874000124 | — | On the market |
| the Wand Handpiece WA-2050-301 | WA-2050-301 | 20618874000121 | — | On the market |
| the Wand Handpiece WA-2050-305 | WA-2050-305 | 10618874000131 | — | On the market |
| the Wand Handpiece WA-2050-305 | WA-2050-305 | 20618874000138 | — | On the market |
| the Wand Handpiece WA-2050A | WA-2050A | 20618874000107 | — | On the market |
| the Wand Handpiece WA-2050A | WA-2050A | 10618874000100 | — | On the market |
Similar devices
Other devices filed under FDA product code EJI (Syringe, Cartridge).
- the Wand Handpiece WA-2050A by Milestone Scientific Inc.
- CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 by Dentsply Midwest
- ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE by ARNOLD TUBER INDUSTRIES
- MINIJECT by Spartan Ultrasonics, Inc.
- MULTI-PURPOSE DENTAL SYRINGE by CENTRIX, INC.
- CompuDent-STA™ Drive Unit STA-5110 by Milestone Scientific Inc.
- Hu-Friedy Dental Cartridge Syringe by HU-FRIEDY MFG CO., LLC
- LIGMAJECT by Alan J. Khedarri D.D.S., Inc.
- Morpheus by Meibach Tech Ltda
- Comfort Control Syringe System by Dentsply Intl.