Precious-Metal/Plastic Attach., Auxill
FDA 510(k) K812360 · Zl-Microdent-Attachments
510(k) numberK812360
Submission
- Device name
- Precious-Metal/Plastic Attach., Auxill
- Applicant
- Zl-Microdent-Attachments
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EGG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990979 | Steco-TitanmagneticsEGG · Traditional | Steco-System-Technik GmbH & Cokg | 09/03/1999SE |
| K950259 | Coupling Device for Dental ProsthesisEGG · Traditional | Dr. Joseph E. Grasso, D.D.S. | 12/06/1996SE |
| K925700 | Zest Anchor Advanced GenerationEGG · Traditional | Zest Anchors, Inc. | 04/07/1994SE |
| K915299 | Cogan Corp Kits of Dental Hand InstrumentsEGG · Traditional | Cogan Corp. | 01/31/1992SE |
| K912435 | Dental Connector Precision AttachmentEGG · Traditional | Metalor Dental USA Corp. | 08/28/1991SE |
| K912567 | Conicast, Intracast, OmecastEGG · Traditional | Metalor Dental USA Corp. | 07/02/1991SE |
| K901928 | Interpore Imz(Castable)Tub/Scret Ret Rigid AttachEGG · Traditional | Interpore Intl. | 07/26/1990SE |
| K900785 | Micro 2 SystemEGG · Traditional | Inodent | 04/16/1990SE |
| K896337 | Dental Bridge Anchoring PinsEGG · Traditional | Gayso Bridge-Tech, Inc. | 01/31/1990SE |
| K895986 | Precision Dental AttachmentsEGG · Traditional | Implant Support Systems, Inc. | 10/18/1989SE |
Questions and answers
When was Precious-Metal/Plastic Attach., Auxill cleared by the FDA?
Precious-Metal/Plastic Attach., Auxill (K812360) received a 510(k) decision of Substantially Equivalent on September 21, 1981, 32 days after the submission was received.
What is the product code of K812360?
The FDA product code is EGG – Attachment, Precision, All, a Class I (low risk) device regulated under 21 CFR 872.3165.