Ear Curette, Various
FDA 510(k) K841001 · Premier Dental Products Co.
510(k) numberK841001
Submission
- Device name
- Ear Curette, Various
- Applicant
- Premier Dental Products Co.
Mchenry, IL, US - Received
- March 9, 1984
- Decision date
- May 29, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JYG – Curette, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932609 | Ear CuretteJYG · Traditional | Ear Tech, Inc. | 07/21/1993SE |
| K852039 | Flex-Loop Flexible Ear CoretteJYG · Traditional | Bionix Corp. | 06/11/1985SE |
| K841354 | CuretteJYG · Traditional | Treace Medical, Inc. | 07/06/1984SE |
| K823916 | Wax Curette TipJYG · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822273 | ENT CurrettesJYG · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822006 | Operative Ear Currettes & Related ItemJYG · Traditional | Kelleher Corp. | 08/12/1982SE |
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| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | 12/06/2022SE |
| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | 08/26/2013SE |
| K083695 | TraxodentMVL · Traditional | 04/28/2009SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
Questions and answers
When was Ear Curette, Various cleared by the FDA?
Ear Curette, Various (K841001) received a 510(k) decision of Substantially Equivalent on May 29, 1984, 81 days after the submission was received.
What is the product code of K841001?
The FDA product code is JYG – Curette, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.