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FDA 510(k)

AMC-20 PORTABLE DENTAL CART MODEL AMC-20

K-Number: K101332 · 2011-04-11

ApplicantAseptico, Inc.
Decision Date2011-04-11
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMC-20 PORTABLE DENTAL CART MODEL AMC-20 is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 2011-04-11 under 510(k) number K101332. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMC-20 PORTABLE DENTAL CART MODEL AMC-20?

AMC-20 PORTABLE DENTAL CART MODEL AMC-20 is a medical device that received FDA 510(k) clearance on 2011-04-11. The listed applicant is Aseptico, Inc.. The 510(k) number is K101332.

When did AMC-20 PORTABLE DENTAL CART MODEL AMC-20 receive FDA 510(k) clearance?

AMC-20 PORTABLE DENTAL CART MODEL AMC-20 received FDA 510(k) clearance on 2011-04-11, under 510(k) number K101332.

Who is the listed applicant for AMC-20 PORTABLE DENTAL CART MODEL AMC-20?

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

What is the FDA product code for AMC-20 PORTABLE DENTAL CART MODEL AMC-20?

The FDA product code for AMC-20 PORTABLE DENTAL CART MODEL AMC-20 is EIA.

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Other records listing Aseptico, 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.

K130693AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEMK111078AEU-26L ELCTRONIC ENDODONTIC SYSTEMK103399GENERAL DENISTRY MOTORK070866ASC-12 PIEZOELECTRIC SCALERK051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101K050201AEU-14CF EXPENDITION

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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