FDA.reportPublic FDA data

EndoRing®

Primary DI
10818365028457
Brand
EndoRing®
Company
US ENDODONTICS, LLC
Model
00859611006488
Catalog number
00859611006488
Device description
EndoRing® Blue e-foam® Insert Refill Pack EndoRing® Combo e-foam® Insert Refill Pack
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365028450PrimaryGS10
10818365028457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365028450008183650284508183650284500818365028450
1081836502845710818365028457

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic instrument chairside holder setA collection of devices intended to be used chairside during a endodontic procedure to facilitate the access, handling, temporary storage and convenient selection of endodontic instruments (e.g., files/rasps). The set may be positioned on a surface or worn by the operator (e.g., ring design) and typically includes a plastic housing/rack, disposable spongy foam inserts for holding delicate and sharp rotary endpieces, holders for fluid containers, colour-coded identification labels/tags, and a ruler to help select an appropriate size instrument. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags#

DUNS number
061317427
Device count
48
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047645351EdgeSequel UtopiaES150421SEES150421SE2023-07-28
00810047645368EdgeSequel UtopiaES150425SEES150425SE2023-07-28
00810047645375EdgeSequel UtopiaES150431SEES150431SE2023-07-28
00810047645382EdgeSequel UtopiaES250421SEES250421SE2023-07-28
00810047645399EdgeSequel UtopiaES250425SEES250425SE2023-07-28
00810047645405EdgeSequel UtopiaES250431SEES250431SE2023-07-28
00810047645412EdgeSequel UtopiaES300421SEES300421SE2023-07-28
00810047645429EdgeSequel UtopiaES300425SEES300425SE2023-07-28
00810047645436EdgeSequel UtopiaES300431SEES300431SE2023-07-28
00810047645443EdgeSequel UtopiaES400421SEES400421SE2023-07-28
00810047645450EdgeSequel UtopiaES400425SEES400425SE2023-07-28
00810047645467EdgeSequel UtopiaES400431SEES400431SE2023-07-28
00810047645474EdgeSequel UtopiaES500421SEES500421SE2023-07-28
00810047645481EdgeSequel UtopiaES500425SEES500425SE2023-07-28
00810047645498EdgeSequel UtopiaES500431SEES500431SE2023-07-28
00810047645504EdgeSequel UtopiaES250621SEES250621SE2023-07-28
00810047645511EdgeSequel UtopiaES250625SEES250625SE2023-07-28
00810047645528EdgeSequel UtopiaES250631SEES250631SE2023-07-28
00810047645535EdgeSequel UtopiaES300621SEES300621SE2023-07-28
00810047645542EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
J003SVN620451Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003SVN650901Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693001Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693011Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693051Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693061Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693071Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26