GoldenDent

FDA Device Registration & Listing · Roseville, MI, US · Registration 3005972890

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005972890
FEI Number
3005972890
Entity Name
GoldenDent
City/State/Country
Roseville, MI, US
Establishment Address
27251 Gratiot Ave, Roseville, MI 48066, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
GoldenDent (Owner Number: 9090600)
Owner / Operator Contact Address
27251 Gratiot Ave., --, Roseville, MI 48066, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

WagoTrix Wedge GoldenDent GoldenDent Laser LX16 and accessories Golden-Taper Flex Series dental mirror Wam Key, MD Guide Spotter GoldenDent Separators GMX 69, Distal Elevator, Buccal Elevator, Lingual Elevator, The Wedge, The Reflector, Cowhorns GoldenDent Flex Series GoldenDent Sutures GoldenDent GoldenForce X-Ray Protective Surgical Gloves O-Star Curing Light X-Star Curing Light O-Star Pro Curnig Light X-Ray Endo Motor Vibraject; Vibraject Clip Brackets, Vibraject Motor and Housing, Vibraject Control Knob PT-S1, PT-S3 / SANDBLASTING POWDER Irriflex Endo Irrigation GoldenDent Physics Forceps SeeMore

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2018-08-22
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2020-08-20
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2020-08-20
NVK Laser, Dental, Soft Tissue General, Plastic Surgery Class 2 878.4810 2023-07-10
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-07-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-07-10
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2020-08-20
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-12-14
EAX Mirror, Mouth Dental Class 1 872.4565 2016-12-30
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2014-03-04
EMN Scaler, Periodontic Dental Class 1 872.4565 2020-12-14
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2020-12-14
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2020-08-20
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2020-12-14
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2021-01-26
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2021-01-26
ELR Post, Root Canal Dental Class 1 872.3810 2020-08-20
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2020-12-14
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2017-03-06
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2022-01-13
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2025-06-03
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2022-01-13
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2015-06-22
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2018-09-04
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2023-08-15
EKM Gutta-Percha Dental Class 1 872.3850 2020-08-20
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2017-09-12
EIG Retractor, All Types Dental Class 1 872.4565 2020-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GoldenDent
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005972890. Last updated year: 2026. Please use registration number 3005972890 when referencing this establishment in official correspondence.
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