FDA.reportPublic FDA data

Triton

Primary DI
00850309007060
Brand
Triton
Company
ASI MEDICAL, INC.
Model
90-1046
Catalog number
90-1046
Device description
Triton Assistant’s System
Published
2016-10-31
Public version status
Update
Distribution status
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
00850309007060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850309007060008503090070608503090070600850309007060

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

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
00850309007770The Glider™ Dental Treatment Station90-21482022-11-22
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
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
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
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08
10817417021538AsepticoASEPTICO, INC.EIA2022-12-08
10817417021545AsepticoASEPTICO, INC.EIA2022-12-08
10817417021552AsepticoASEPTICO, INC.EIA2022-12-08
10817417021569AsepticoASEPTICO, INC.EIA2022-12-08
10817417021576AsepticoASEPTICO, INC.EIA2022-12-08
10817417021583AsepticoASEPTICO, INC.EIA2022-12-08
10817417021590AsepticoASEPTICO, INC.EIA2022-12-08
10817417021606AsepticoASEPTICO, INC.EIA2022-12-08
10817417021613AsepticoASEPTICO, INC.EIA2022-12-08
10817417021835AsepticoASEPTICO, INC.EIA2022-12-08
10817417021842AsepticoASEPTICO, INC.EIA2022-12-08