MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
FDA 510(k) clearance K903007 · decided 1990-09-19
Clearance details
- K-number
- K903007
- Device name
- MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
- Applicant
- Habley Medical Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-11
- Decision date
- 1990-09-19
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EJI
- Device class
- 2
- Regulation number
- 872.6770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Laguana Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LeEject 2 Dental Syringe and Needle System (K171254) | Advanced Technology and Capital, Inc. | 2017-11-16 |
| Miltex N-Tralig Intraligamentary Syringe (K142414) | Integra LifeSciences Corporation | 2014-10-30 |
| HU-FRIEDY DENTAL CARTRIDGE SYRINGE (K120659) | Hu-Friedy Mfg. Co., LLC | 2012-11-06 |
| ANESTHESIA INJECTION TOOL SET (K113247) | Ki Works Co., Ltd. | 2012-03-27 |
| MORPHEUS (K082249) | Meibach Tech Ltda | 2009-12-31 |
| ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (K092943) | Arnold Tuber Industries | 2009-12-11 |
| MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT (K083796) | Miltex, Inc. | 2009-03-09 |
| DENJECTOR (K081694) | Dxm Co., Ltd. | 2008-09-12 |
| COMPUDENT STA (K061904) | Milestone Scientific, Inc. | 2006-08-08 |
| MIRAMATIC SAFE SYRINGE SYSTEM (K043322) | Hager Worldwide, Inc. | 2005-07-21 |
| EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES (K040671) | Anthogyr | 2004-12-14 |
| SAFETYWAND DISPOSABLE HANDPIECE (K023722) | Spintech, Inc. | 2003-09-02 |
Recalls involving this device
No recalls on record reference this clearance.