FDA 510(k)

HERA H

K-Number: K883508 · 1988-09-22

Decision Date1988-09-22

Product CodeEJT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HERA H 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 K883508. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERA H?

HERA H 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 K883508.

When did HERA H receive FDA 510(k) clearance?

HERA H received FDA 510(k) clearance on 1988-09-22, under 510(k) number K883508.

Who is the listed applicant for HERA H?

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 HERA H?

The FDA product code for HERA H is EJT.

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 60 K883511ALBABOND E K883509HERAEUS DG 63 K883510DEGUPAL 4 K883507HERAEUS C SPECIAL K883512HERAEUS WHITE

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Related Devices (Code: EJT)

K052463PROMETAL HN86Prometal Technologies K041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG K040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

Official Source

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