FDA.reportPublic FDA data

Dental Engineering Lab-TFRK

Primary DI
00850001745123
Brand
Dental Engineering Lab-TFRK
Company
DENTAL ENGINEERING LABORATORIES, LLC
Model
GG-3M
Catalog number
GG-3M
Device description
Modified Gates Glidden Bur
Published
2018-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001745123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001745123008500017451238500017451230850001745123

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-963-2118info@delengineeringlab.com

Regulatory Flags#

DUNS number
026444360
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001745826Dental Engineering Lab-TFRKZTip-S7211919-Z2024-09-20
00850001745833Dental Engineering Lab-TFRKZTip-E7210519-Z2024-09-20
00850001745116Dental Engineering Lab-TFRKTFRK-MTTFRK-MT2018-10-08
00850001745130Dental Engineering Lab-TFRKTFRK-CSTFRK-CS2018-10-08
00850001745628Dental Engineering Lab-TFRKTFRK-SET+2022-08-22
00850001745635Dental Engineering Lab-TFRKTFRK-EMS+2022-08-22
00850001745642PB Access90000002022-08-22
00850001745659PB Access90000102022-08-22
00850001745666PB Access90000112022-08-22
00850001745673PB Access90000122022-08-22
00850001745680PB Access90000132022-08-22
00850001745697PB Access90000142022-08-22
00850001745703PB Access90000152022-08-22
00850001745710PB Access90000162022-08-22
00850001745727PB Access90000172022-08-22
10850001745656PB Access90000012022-08-22
10850001745663PB Access90000022022-08-22
10850001745670PB Access90000032022-08-22
10850001745687PB Access90000042022-08-22
10850001745694PB Access90000052022-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D661R100699C1AlpenCOLTENE/WHALEDENT INCEJL2026-06-05
D8120513291BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
D8120513301BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEJL2026-06-01
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
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ESUNC463140185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07
ESUNC48L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07