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Data / Medical devices / United States / GoldenDent

GoldenDent: FDA-registered device maker in Roseville, MI, United States, 11 510(k) clearances

GoldenDent is registered with the FDA (registration 3005972890) in Roseville, MI, United States. It lists 40 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 28, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch GoldenDent
FDA registration number
3005972890
Address
27251 Gratiot Ave, Roseville, MI, United States, 48066
Owner or operator
GoldenDent (9090600)
Roles
Repackager or relabeler, Specification developer
First device listed
May 1, 2013
Registered through
2026
Brand names listed
AP-A, APEX Locator, Anatomical Matrix, Deep Margin Elevation Wedge, Dental Air Polishing Handpiece, Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment, Endo Motor, FlashMax and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
AirbrushKOJ2Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Repackager or relabeleraccessdata.fda.gov
Drill, Bone, PoweredDZI2Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Instrument, Contouring, Matrix, OperativeEKF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Repackager or relabeleraccessdata.fda.gov
Laser, Dental, Soft TissueNVK2Repackager or relabeleraccessdata.fda.gov
Locator, Root ApexLQYURepackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeleraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Repackager or relabeleraccessdata.fda.gov
Radiographic Protective GloveIWP1Repackager or relabeleraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Repackager or relabeleraccessdata.fda.gov
Retainer, MatrixJEP1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 28, 2022K221548Dental Air Polishing HandpieceEFBSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
March 10, 2022K210367D-Laser Blue, D-Laser 16NVKSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
January 13, 2022K203706Dental Electric MotorEBWSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 10, 2021K203615Dental Scaler and Air PolisherELCSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
September 27, 2021K212080Imaging Plate Scanner, i-ScanMUHSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
May 10, 2021K203320Endo MotorEKXSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 18, 2018K181087Apex Locator, DPEX IIILQYSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
November 18, 2011K111290PIEZO BONE SURGERYDZISubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
April 30, 2008K073614WG-SURGICAL SUTURES WITH NEEDLENEWSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
March 19, 2008K080025LED.L, LED.M, LED.G, LED.BEBZSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
November 28, 2000K002991ZAP DUAL CURING LIGHTEBZSubstantially EquivalentSoft-Core Texas, Inc.accessdata.fda.gov

Compare with other makers

Updated September 28, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.