510(k) K991888
- Device
- MINIJECT
- Applicant
- SPARTAN ULTRASONICS, INC.
- 510(k) number
- K991888
- Product code
- EJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-25
- Date received
- 1999-06-02
- Regulation
- 872.6770
- Classification name
- Syringe, Cartridge
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALDO EAGLE
- Address
- 1663 Fenton Business Park Ct. Fenton MO US 63026 63026
FDA Registration Numbers#
- 3014334038
- 3003882399
- 3023657851
- 3015156396
- 3005587147
- 3038718579
- 3014150341
- 3005809810
- 1423929
- 3004215117
- 3002987375
- 1416605
- 3013946322
- 3014937043
- 2024980
- 3017604
- 8041151
- 3014829979
- 2183301
- 3009968482
- 3014953747
- 8040278
- 3014683120
- 3014615644
- 9614075
- 3005973280
- 3012185136
- 3015422158
- 3010373494
- 3004082685
- 3003963832
- 9680515
- 3007156625
- 3031231776
- 3017352116
- 3001084743
- 1419489
- 3008719017
- 3005581016
- 3010288346
- 3021023132
- 3015397788
- 3004193466
- 9613230
- 3000126234
- 3008242564
- 3012421607
- 3043625057
- 3003882387
- 3013552516
- 2520279
- 2246990
- 3009170227
- 3013934196
- 3008770655
- 3024787345
- 1421101
- 3012494290
- 3003988575
- 3018077478
- 3004530184
- 9616119
- 9680244
- 3013503739
- 3007497008
- 9610964
- 3003418325
- 3012507533
- 3008579121
- 3008808049
- 3013547731
- 3008280196
- 1058726
Source Documents#
Other 510(k) Records For Product Code EJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017-11-16 |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014-10-30 |
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg. Co., LLC | 2012-11-06 |
| K113247 | ANESTHESIA INJECTION TOOL SET | Ki Works Co., Ltd. | 2012-03-27 |
| K082249 | MORPHEUS | Meibach Tech Ltda | 2009-12-31 |
| K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | 2009-12-11 |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | 2009-03-09 |
| K081694 | DENJECTOR | Dxm Co., Ltd. | 2008-09-12 |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | 2006-08-08 |
| K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | Hager Worldwide, Inc. | 2005-07-21 |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | Anthogyr | 2004-12-14 |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | 2003-09-02 |
| K022959 | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | 2003-02-05 |
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | 2000-10-13 |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | 2000-09-28 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases