ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
Device Facts
| Record ID | K002168 |
|---|---|
| Device Name | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE |
| Applicant | Ronvig Instruments, Ltd. |
| Product Code | EJI · Dental |
| Decision Date | Oct 13, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.6770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
