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Pelton & Crane Co.

Also registered as Pelton & Crane

Country not established

Devices
16
FDA recalls
9

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Pelton & Crane Co. makes

Pelton & Crane Co. makes dental chairs, dental treatment centers, digital radiography systems, ultrasonic scalers, water purifiers for dental use, and related dental equipment such as the SIEMENS SIRONA(R) DENTAL CHAIR, ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD, HELIODENT DS, RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT, SIROLUX FANTASTIC, HELIODENT MD, CEREC 2, SPIRIT II AND SPIRIT TREATMENT CENTER, SIDEXIS DIGITAL RADIOGRAPHY SYSTEM, ORTHOPHOS 3/ ORTHOPHOS 3C, OPTISON ULTRASONIC SCALER, and BI-CENTRIC SYSTEM.

The devices in the portfolio are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Siemens Sirona(R) Dental Chair Ref K863484

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orthophos Plus And Orthophos Plus/Cd Ref K972249

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Heliodent Ds Ref K960819

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Resubmitted Water Purifier For Use W/Dental Treat Ref K901672

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sirolux Fantastic Ref K935390

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Heliodent Md Ref K950030

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cerec 2 Ref K950299

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Spirit Ii And Spirit Treatment Center Ref K946187

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • P50 Series Dental Operative Unit and Accessories Ref K171872

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sidexis Digital Radiography System Ref K972168

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orthophos 3/ Orthophos 3C Ref K936068

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optison Ultrasonic Scaler Ref K837382

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Bi-Centric System Ref K760404

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Spirit Ref K143696

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Spirit S1/S2 Ref K962071

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Delta Ref K945117

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-16 of 16

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 9 recalls initiated by Pelton & Crane Co., the earliest on 2010-02-09 and the most recent on 2012-02-20. By recorded status: 9 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 20 Feb 2012 Z-1177-2012 Not yet classified Terminated Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up. Distribution: (USA) Nationwide Distribution Submission number: K946187

  • 2011

    • 4 Mar 2011 Z-1850-2011 Unclassified (pre-2012) Terminated The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair. Distribution: Distribution to USA, Canada, and the Netherlands.
    • 4 Mar 2011 Z-1851-2011 Unclassified (pre-2012) Terminated The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair. Distribution: Distribution to USA, Canada, and the Netherlands.

  • 2010

    • 24 Feb 2010 Z-1179-2010 Unclassified (pre-2012) Terminated Magnetic headrests may affect patients with implantable pacemakers and defibrillators. Distribution: Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. Submission number: K760404
    • 24 Feb 2010 Z-1180-2010 Unclassified (pre-2012) Terminated Magnetic headrests may affect patients with implantable pacemakers and defibrillators. Distribution: Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. Submission number: K760404
    • 24 Feb 2010 Z-1324-2010 Unclassified (pre-2012) Terminated Magnetic headrests may affect patients with implantable pacemakers and defibrillators. Distribution: Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. Submission number: K760404
    • 24 Feb 2010 Z-1325-2010 Unclassified (pre-2012) Terminated Magnetic headrests may affect patients with implantable pacemakers and defibrillators. Distribution: Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. Submission number: K760404
    • 24 Feb 2010 Z-1326-2010 Unclassified (pre-2012) Terminated Magnetic headrests may affect patients with implantable pacemakers and defibrillators. Distribution: Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany. Submission number: K760404
    • 9 Feb 2010 Z-1311-2010 Unclassified (pre-2012) Terminated The Dental Chair lacks a valid Device History Record. Distribution: Nationwide distribution: NC

Frequently asked questions

How many devices does Pelton & Crane Co. have in the registry?

The registry currently lists 16 devices for Pelton & Crane Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pelton & Crane Co.'s devices?

Among its 16 most recently registered devices, Pelton & Crane Co. has devices listed in FDA 510(k) (16 devices).

What risk classes do Pelton & Crane Co.'s devices fall under?

Among its 16 most recently registered devices, the classes recorded for Pelton & Crane Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Pelton & Crane Co.?

FDA recall records list 9 recalls initiated by Pelton & Crane Co., the most recent initiated on 20 Feb 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Pelton & Crane Co. in the registry?

The most recently registered devices listed for Pelton & Crane Co. include SIEMENS SIRONA(R) DENTAL CHAIR, ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD, HELIODENT DS and RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT.

Generated automatically from registry data and not verified by a human reviewer.