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FDA 510(k)

SR-IVOLEN TRAY MATERIAL

K-Number: K863421 · 1986-11-03

ApplicantIvoclar USA, Inc.
Decision Date1986-11-03
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR-IVOLEN TRAY MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar USA, Inc.. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K863421. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR-IVOLEN TRAY MATERIAL?

SR-IVOLEN TRAY MATERIAL is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Ivoclar USA, Inc.. The 510(k) number is K863421.

When did SR-IVOLEN TRAY MATERIAL receive FDA 510(k) clearance?

SR-IVOLEN TRAY MATERIAL received FDA 510(k) clearance on 1986-11-03, under 510(k) number K863421.

Who is the listed applicant for SR-IVOLEN TRAY MATERIAL?

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

What is the FDA product code for SR-IVOLEN TRAY MATERIAL?

The FDA product code for SR-IVOLEN TRAY MATERIAL is EBH.

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Other records listing Ivoclar USA, 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.

K012877HIGH GOLD PALLADIUM FREE CERAMIC SOLDERK981264ARISTON PHCK980986PROCADK941849PROVIPONT C&BK923644DW243-64K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN

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Related Devices (Code: EBH)

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.

K933745PERMAGEN UNIVERSAL BONDING RESINBio-Systems ResearchK930487PALATRAY LC MINTHeraeus Kulzer, Inc.K923979LC TRAY MATERIALDentsply Intl.K923549PALADISC LCHeraeus Kulzer, Inc.K912820POLYESTER RESIN HAND MOLDED TRAYE&D Dental Products, Inc.K905058PALAVIT LKulzer, 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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