Conicast, Intracast, Omecast

FDA 510(k) K912567 · Metalor Dental USA Corp.

Substantially Equivalent

510(k) numberK912567

Submission

Device name
Conicast, Intracast, Omecast
Applicant
Metalor Dental USA Corp.
Rockville Centre, NY, US
Received
June 11, 1991
Decision date
July 2, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EGG – Attachment, Precision, All
Device class
Class I (low risk)
Regulation
21 CFR 872.3165
Specialty
Dental

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K925700Zest Anchor Advanced GenerationEGG · Traditional Zest Anchors, Inc.04/07/1994SE
K915299Cogan Corp Kits of Dental Hand InstrumentsEGG · Traditional Cogan Corp.01/31/1992SE
K912435Dental Connector Precision AttachmentEGG · Traditional Metalor Dental USA Corp.08/28/1991SE
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K900785Micro 2 SystemEGG · Traditional Inodent04/16/1990SE
K896337Dental Bridge Anchoring PinsEGG · Traditional Gayso Bridge-Tech, Inc.01/31/1990SE
K895986Precision Dental AttachmentsEGG · Traditional Implant Support Systems, Inc.10/18/1989SE
K891119T.R.S.: Tooth Replacement SystemEGG · Traditional Health Technology of America, Inc.04/17/1989SE

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Questions and answers

When was Conicast, Intracast, Omecast cleared by the FDA?

Conicast, Intracast, Omecast (K912567) received a 510(k) decision of Substantially Equivalent on July 2, 1991, 21 days after the submission was received.

What is the product code of K912567?

The FDA product code is EGG – Attachment, Precision, All, a Class I (low risk) device regulated under 21 CFR 872.3165.