FDA.reportPublic FDA data

Advanced Endodontic System

Primary DI
00850309007305
Brand
Advanced Endodontic System
Company
ASI MEDICAL, INC.
Model
90-2134E/C
Catalog number
90-2134E/C
Device description
Advanced Endodontic 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
DZIDrill, Bone, Powered
EBZActivator, Ultraviolet, For Polymerization
EFAHandpiece, Belt And/Or Gear Driven, Dental
EIAUnit, Operative Dental
EKRPlugger, Root Canal, Endodontic
EKXHandpiece, Direct Drive, Ac-Powered
ELCScaler, Ultrasonic
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
EBZActivator, Ultraviolet, For PolymerizationDental2
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1
EIAUnit, Operative DentalDental1
EKRPlugger, Root Canal, EndodonticDental1
EKXHandpiece, Direct Drive, Ac-PoweredDental1
ELCScaler, UltrasonicDental2
LQYLocator, Root ApexUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123139000ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIESAsi Medical, Inc.2013-03-28ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850309007305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850309007305008503090073058503090073050850309007305

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
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

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Primary DI, Brand, Company table
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