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FDA 510(k)

CRYSTAL ULTRA

K-Number: K130654 · 2013-09-24

ApplicantDental Laboratory Milling Supplies, LLC (Dlms)
Decision Date2013-09-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRYSTAL ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Dental Laboratory Milling Supplies, LLC (Dlms). It received FDA 510(k) clearance on 2013-09-24 under 510(k) number K130654. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTAL ULTRA?

CRYSTAL ULTRA is a medical device that received FDA 510(k) clearance on 2013-09-24. The listed applicant is Dental Laboratory Milling Supplies, LLC (Dlms). The 510(k) number is K130654.

When did CRYSTAL ULTRA receive FDA 510(k) clearance?

CRYSTAL ULTRA received FDA 510(k) clearance on 2013-09-24, under 510(k) number K130654.

Who is the listed applicant for CRYSTAL ULTRA?

The FDA 510(k) record lists Dental Laboratory Milling Supplies, LLC (Dlms) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTAL ULTRA?

The FDA product code for CRYSTAL ULTRA is EIH.

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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