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FDA 510(k)

FLEXO DENTAL RESIN MATERIAL

K-Number: K061501 · 2006-07-26

ApplicantAci, Inc.
Decision Date2006-07-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXO DENTAL RESIN MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Aci, Inc.. It received FDA 510(k) clearance on 2006-07-26 under 510(k) number K061501. 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 FLEXO DENTAL RESIN MATERIAL?

FLEXO DENTAL RESIN MATERIAL is a medical device that received FDA 510(k) clearance on 2006-07-26. The listed applicant is Aci, Inc.. The 510(k) number is K061501.

When did FLEXO DENTAL RESIN MATERIAL receive FDA 510(k) clearance?

FLEXO DENTAL RESIN MATERIAL received FDA 510(k) clearance on 2006-07-26, under 510(k) number K061501.

Who is the listed applicant for FLEXO DENTAL RESIN MATERIAL?

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

What is the FDA product code for FLEXO DENTAL RESIN MATERIAL?

The FDA product code for FLEXO DENTAL RESIN MATERIAL is EBI.

Related Clinical Trials

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.

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Other records listing Aci, 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.

K063753GFX NERVE ABLATION SYSTEM

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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