Instrument, Filling, Plastic, Dental
The Dental Plastic Filling Instrument is a hand instrument with a smooth, non-stick tip used to place, adapt, and condense tooth-colored restorative materials such as composite resin or glass ionomer into prepared cavities. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIY, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIY
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871909 | COMPOSITE RESTORATIVE CARRIER | May 27, 1987 | Substantially Equivalent | Dentsply Intl. |
| K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | Jul 02, 1985 | Substantially Equivalent | Artiberia |
| K833955 | NOVEL DISPENSER/PACKAGE | Jan 03, 1984 | Substantially Equivalent | Dentsply Intl. |
| K830776 | MICROFIL CONTOURING INSTRUMENTS | Apr 28, 1983 | Substantially Equivalent | Almore Intl., Inc. |
| K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
FEI Numbers
This FDA classification entry is associated with 177 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 177 registration numbers. Click on an entry to view related FDA registrations.