Dental Instruments - Plastic Instruments
FDA 510(k) K823323 · Miltex, Inc.
510(k) numberK823323
Submission
- Device name
- Dental Instruments - Plastic Instruments
- Applicant
- Miltex, Inc.
Mchenry, IL, US - Received
- November 8, 1982
- Decision date
- November 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871909 | Composite Restorative CarrierEIY · Traditional | Dentsply Intl. | 05/27/1987SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | Artiberia | 07/02/1985SE |
| K833955 | Novel Dispenser/PackageEIY · Traditional | Dentsply Intl. | 01/03/1984SE |
| K830776 | Microfil Contouring InstrumentsEIY · Traditional | Almore Intl., Inc. | 04/28/1983SE |
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| K050570 | Miltex Rigid Sterilization Container SystemKCT · Traditional | 07/25/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | 03/04/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
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Questions and answers
When was Dental Instruments - Plastic Instruments cleared by the FDA?
Dental Instruments - Plastic Instruments (K823323) received a 510(k) decision of Substantially Equivalent on November 24, 1982, 16 days after the submission was received.
What is the product code of K823323?
The FDA product code is EIY – Instrument, Filling, Plastic, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.