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FDA 510(k)

BELMAX CM MODEL X168

K-Number: K062529 · 2006-10-05

ApplicantTakara Belmont USA, Inc.
Decision Date2006-10-05
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELMAX CM MODEL X168 is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062529. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELMAX CM MODEL X168?

BELMAX CM MODEL X168 is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K062529.

When did BELMAX CM MODEL X168 receive FDA 510(k) clearance?

BELMAX CM MODEL X168 received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062529.

Who is the listed applicant for BELMAX CM MODEL X168?

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

What is the FDA product code for BELMAX CM MODEL X168?

The FDA product code for BELMAX CM MODEL X168 is MUH.

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 Takara Belmont 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.

K102456INTRAORAL BELSENSOR GOLDK072273BELMONT QUOLIS 5000 SERIES DENTAL UNITK041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CMK042260PHOT-X II, MODEL 303K040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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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