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FDA 510(k)

MUCOPREN SOFT RELINING SYSTEM

K-Number: K983357 · 1998-11-13

ApplicantRoydent Dental Products, Inc.
Decision Date1998-11-13
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MUCOPREN SOFT RELINING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roydent Dental Products, Inc.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K983357. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUCOPREN SOFT RELINING SYSTEM?

MUCOPREN SOFT RELINING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Roydent Dental Products, Inc.. The 510(k) number is K983357.

When did MUCOPREN SOFT RELINING SYSTEM receive FDA 510(k) clearance?

MUCOPREN SOFT RELINING SYSTEM received FDA 510(k) clearance on 1998-11-13, under 510(k) number K983357.

Who is the listed applicant for MUCOPREN SOFT RELINING SYSTEM?

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

What is the FDA product code for MUCOPREN SOFT RELINING SYSTEM?

The FDA product code for MUCOPREN SOFT RELINING SYSTEM is EBI.

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Other records listing Roydent Dental Products, 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.

K984037CORE-IDEK954281PANASIL IMPRESSION MATERIAL

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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