FDA.reportPublic FDA data

The Glider™ Dental Treatment Station

Primary DI
00850309007770
Brand
The Glider™ Dental Treatment Station
Company
ASI MEDICAL, INC.
Model
90-2148
Device description
Integrated delivery system with up to two handpiece connections, dual air/water syringes and titanium saliva ejector and high-volume evacuator. Delivery system features programmable electro-mechanically adjusted height to allow for sit down to stand up procedures and Wilsonart solid surface worktop and heavy duty 3” casters. Storage includes two side rails for accessory brackets, saline bag hooks, and sharps containers. Includes back rail with two storage tubs.
Published
2022-11-22
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110481000TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASEAsi Medical, Inc.2012-04-05EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850309007770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850309007770008503090077708503090077700850309007770

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808695159
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850309007763Advanced Dental/ Endodontics Systems - Umbilical Cart90-2143DS2021-08-17
00850309007497Advanced Dental/ Endodontics Systems - Umbilical Cart90-2143ES2021-03-02
00850309007480Standard Triton Self-Contained Delivery Systems90-26252020-11-13
00850309007473Extended Worktop - Umbilical Carts90-20422020-08-20
00850309007411Extended Worktop - Umbilical Carts90-1044S90-1044S2019-07-25
00850309007428Extended Worktop - Self-Contained Carts90-2006S90-2006S2019-07-25
00850309007435Extended Worktop - Self-Contained Carts90-2026S90-2026S2019-07-25
00850309007442Extended Worktop - Umbilical Carts90-2044S90-2044S2019-07-25
00850309007459Extended Worktop - Self-Contained Carts90-200690-2002019-07-25
00850309007466Extended Worktop - Umbilical Carts90-204490-20442019-07-25
00850309007022N/A90-204590-20452016-10-31
00850309007053N/A90-205490-20542016-10-31
00850309007060Triton90-104690-10462016-10-31
00850309007084Triton90-204690-20462016-10-31
00850309007091Triton90-201590-20152016-10-31
00850309007107Triton90-202190-20212016-10-31
00850309007114Triton90-202590-20252016-10-31
00850309007121Triton90-2025M90-2025M2016-10-31
00850309007138Advanced Dental System90-2110D90-2110D2016-10-31
00850309007145Advanced Endodontic System90-2110E90-2110E2016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031162Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975659690060YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690077YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690107YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08