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FDA 510(k)

PTM SYSTEM

K-Number: K041335 · 2004-06-16

ApplicantDentsply International
Decision Date2004-06-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PTM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K041335. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTM SYSTEM?

PTM SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Dentsply International. The 510(k) number is K041335.

When did PTM SYSTEM receive FDA 510(k) clearance?

PTM SYSTEM received FDA 510(k) clearance on 2004-06-16, under 510(k) number K041335.

Who is the listed applicant for PTM SYSTEM?

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

What is the FDA product code for PTM SYSTEM?

The FDA product code for PTM SYSTEM is EIH.

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Other records listing Dentsply International 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.

K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSK061580ECLIPSE WAX REMOVERK060837IN-OVATION CK053368INTERPROXIMAL REDUCTION SYSTEMK052370CP BRACKET SYSTEMK052097CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

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Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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