Syringe, Restorative And Impression Material
The Restorative and Impression Material Syringe is a dental instrument used to precisely inject and place restorative materials such as composite resin or impression materials into prepared cavities or impression trays, ensuring accurate placement and minimizing voids. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EID, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EID
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941431 | BONE GRAFT DELIVERY SYRINGES | Jul 12, 1994 | Substantially Equivalent | Bio-Interfaces, Inc. |
| K913974 | ACCESS IMPRESSION BARREL | Feb 25, 1992 | Substantially Equivalent | Centrix, Inc. |
| K873153 | CAULK'S VPS CARTRIDGE SYSTEM | Sep 16, 1987 | Substantially Equivalent | Dentsply Intl. |
| K871937 | IMPRESSION SYRINGE | Jun 05, 1987 | Substantially Equivalent | Dentsply Intl. |
| K863998 | COLTENE JET-MIXER | Oct 30, 1986 | Substantially Equivalent | Coltene, Inc. |
| K853282 | CENTRIX RIBBON TUBES | Aug 23, 1985 | Substantially Equivalent | Centrix, Inc. |
| K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Apr 29, 1985 | Substantially Equivalent | Unitek Corp. |
| K812680 | G-C IMPRESSION SYRINGE | Oct 06, 1981 | Substantially Equivalent | G-C Intl. Corp. |
| K812277 | PRISMA-FIL COMPULES | Sep 08, 1981 | Substantially Equivalent | Caulk Co., Div. Dentsply |
| K811582 | THE PLACER | Jul 28, 1981 | Substantially Equivalent | Cavitron Corp. |
| K781977 | APPLICATOR, LEE IMPRESSION | Dec 20, 1978 | Substantially Equivalent | Lee Pharmaceuticals |
| K770931 | APPLIC SYSTEM APPLIER, ESPE | Jun 03, 1977 | Substantially Equivalent | Espe GmbH (Us) |
| K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | Jun 02, 1977 | Substantially Equivalent | Espe GmbH (Us) |
FEI Numbers
This FDA classification entry is associated with 166 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 166 registration numbers. Click on an entry to view related FDA registrations.