Elevator - Various
FDA 510(k) K841011 · Premier Dental Products Co.
510(k) numberK841011
Submission
- Device name
- Elevator - Various
- Applicant
- Premier Dental Products Co.
Mchenry, IL, US - Received
- March 9, 1984
- Decision date
- June 15, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EMS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931329 | Dental Instruments Curette PeriodontalEMS · Traditional | Minnesota Prophy Power, Inc. | 01/27/1994SE |
| K872091 | Currettes, Alveolar (Molt and Miller)EMS · Traditional | Military Engineering, Inc. | 07/31/1987SE |
| K870590 | Curette, Periodontal, Columbia UniversityEMS · Traditional | Military Engineering, Inc. | 04/16/1987SE |
| K834072 | Instrument, DentalEMS · Traditional | Venture Technology, Inc. | 02/21/1984SE |
| K823319 | Dental Instruments - ScalersEMS · Traditional | Miltex, Inc. | 11/24/1982SE |
| K821789 | Beach Curette No. 2 and No. 3 T.G.EMS · Traditional | Pacific Dental Corp. | 07/06/1982SE |
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| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
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Questions and answers
When was Elevator - Various cleared by the FDA?
Elevator - Various (K841011) received a 510(k) decision of Substantially Equivalent on June 15, 1984, 98 days after the submission was received.
What is the product code of K841011?
The FDA product code is EMS – Curette, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.