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FDA 510(k)

HERAEUS DG 63

K-Number: K883509 · 1988-09-22

ApplicantDegussa Dental, Inc.
Decision Date1988-09-22
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERAEUS DG 63 is the device name listed in this FDA 510(k) record. The listed applicant is Degussa Dental, Inc.. It received FDA 510(k) clearance on 1988-09-22 under 510(k) number K883509. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERAEUS DG 63?

HERAEUS DG 63 is a medical device that received FDA 510(k) clearance on 1988-09-22. The listed applicant is Degussa Dental, Inc.. The 510(k) number is K883509.

When did HERAEUS DG 63 receive FDA 510(k) clearance?

HERAEUS DG 63 received FDA 510(k) clearance on 1988-09-22, under 510(k) number K883509.

Who is the listed applicant for HERAEUS DG 63?

The FDA 510(k) record lists Degussa Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERAEUS DG 63?

The FDA product code for HERAEUS DG 63 is EJS.

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Other records listing Degussa Dental, Inc. as applicant

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.

K883758ALBABOND 60K883511ALBABOND EK883508HERA HK883507HERAEUS C SPECIALK883510DEGUPAL 4K883512HERAEUS WHITE

View all 25 devices →

Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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