FDA.reportPublic FDA data

Advanced Endodontic System

Primary DI
00850309007183
Brand
Advanced Endodontic System
Company
ASI MEDICAL, INC.
Model
90-2125E
Catalog number
90-2125E
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
00850309007183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850309007183008503090071838503090071830850309007183

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic wound closure threadA sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.

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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