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FDA 510(k)

A-DEC 200 DENTAL SYSTEM

K-Number: K102234 · 2010-11-24

ApplicantA-Dec, Inc.
Decision Date2010-11-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-DEC 200 DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A-Dec, Inc.. It received FDA 510(k) clearance on 2010-11-24 under 510(k) number K102234. 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 A-DEC 200 DENTAL SYSTEM?

A-DEC 200 DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-24. The listed applicant is A-Dec, Inc.. The 510(k) number is K102234.

When did A-DEC 200 DENTAL SYSTEM receive FDA 510(k) clearance?

A-DEC 200 DENTAL SYSTEM received FDA 510(k) clearance on 2010-11-24, under 510(k) number K102234.

Who is the listed applicant for A-DEC 200 DENTAL SYSTEM?

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

What is the FDA product code for A-DEC 200 DENTAL SYSTEM?

The FDA product code for A-DEC 200 DENTAL SYSTEM is EIA.

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Other records listing A-Dec, 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.

K213932A-dec 300, A-dec 500K100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMK082716A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43K082827A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENTK082985A-DEC 334/335 DELIVERY SYSTEMK070663A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT

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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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