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FDA 510(k)

DENTAL TRAY, STERILE, DISPOSABLE

K-Number: K974238 · 1998-02-04

ApplicantTrinity Laboratories, Inc.
Decision Date1998-02-04
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL TRAY, STERILE, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1998-02-04 under 510(k) number K974238. 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 DENTAL TRAY, STERILE, DISPOSABLE?

DENTAL TRAY, STERILE, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1998-02-04. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K974238.

When did DENTAL TRAY, STERILE, DISPOSABLE receive FDA 510(k) clearance?

DENTAL TRAY, STERILE, DISPOSABLE received FDA 510(k) clearance on 1998-02-04, under 510(k) number K974238.

Who is the listed applicant for DENTAL TRAY, STERILE, DISPOSABLE?

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

What is the FDA product code for DENTAL TRAY, STERILE, DISPOSABLE?

The FDA product code for DENTAL TRAY, STERILE, DISPOSABLE is EIA.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLEK964921BASIC BIOPSY TRAY. DISPOSABLE, STERILE

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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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