Home GUDID 00860013171742 Keles Keyless Expander
Primary DI 00860013171742
Brand Keles Keyless Expander
Company Aegis Star Dental Technologies Inc.
Model KKE1-12
Device description KKE-Keles Keyless Expander 12mm with Legs
Published 2024-12-09
Public version status New
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name DYJ Retainer, Screw Expansion, Orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYJ Retainer, Screw Expansion, Orthodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860013171742 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860013171742 00860013171742 860013171742 0860013171742
GMDN Terms# Term, Definition table Term Definition Orthodontic palate expander screw, self-removable An orthodontic device intended to be used as part of a self-removable palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is not fixed to the oral cavity so that it can be temporarily removed by the patient during the treatment period (e.g., for eating). This is a reusable device.
Regulatory Flags# DUNS number 119341607 Device count 1 DM exempt true Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850070544849 Retainer - Natural Sprintray, Inc. DYJ 2026-07-29 00850070544856 Retainer - Black Sprintray, Inc. DYJ 2026-07-29 00850070544863 Retainer - Pink Sprintray, Inc. DYJ 2026-07-29 00850070544870 Retainer - Neon Green Sprintray, Inc. DYJ 2026-07-29 08033707106616 LEONE SPA LEONE SPA DYJ 2026-07-22 08033707106623 LEONE SPA LEONE SPA DYJ 2026-07-22 08033707106630 LEONE SPA LEONE SPA DYJ 2026-07-22 08033707106647 LEONE SPA LEONE SPA DYJ 2026-07-22 08800113200210 NT-TAINER SMILECAD DYJ 2026-07-22 06975527188057 MOLEKUR Shanghai Coherz Technology Co., Ltd. DYJ 2026-06-04 06975527188408 MOLEKUR Shanghai Coherz Technology Co., Ltd. DYJ 2026-06-04 08033707104513 LEONE SPA LEONE SPA DYJ 2026-05-28 00840456221761 JMU JMU DENTAL, INC DYJ 2026-05-11 00840456221778 JMU JMU DENTAL, INC DYJ 2026-05-11 D775AHAD0 Hawley Retainer with Adams Clasps Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775AHAR0 Hawley Retainer with Arrow Clasps Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775AHBC0 Hawley Retainer with Ball Clasps Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775AHCC0 Hawley Retainer with Circumferential Clasps Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775BMARPEL0 MARPE Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775BMARPEP0 MARPE Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 D775BMMT0 Memotain Great Lakes Dental Technologies, Ltd. DYJ 2026-05-10 00197998216633 Clarity™ Solventum Orthodontics Corporation DYJ 2026-04-25 10371347023326 Advance Dental Products The Atlanta Dental Supply Company DYJ 2026-04-14 10371347023333 Advance Dental Products The Atlanta Dental Supply Company DYJ 2026-04-14 10371347023340 Advance Dental Products The Atlanta Dental Supply Company DYJ 2026-04-14 10371347023357 Advance Dental Products The Atlanta Dental Supply Company DYJ 2026-04-14 D775AEA0 Expansion Appliance Great Lakes Dental Technologies, Ltd. DYJ 2026-04-13 D775AH0 Hawley Retainer Great Lakes Dental Technologies, Ltd. DYJ 2026-04-13 D775BKS0 Keles Slider Great Lakes Dental Technologies, Ltd. DYJ 2026-04-13 00190746202766 PowerScope AMERICAN ORTHODONTICS CORPORATION DYJ 2026-04-08