FDA.reportPublic FDA data

Dental Engineering Lab-TFRK

Primary DI
00850001745628
Brand
Dental Engineering Lab-TFRK
Company
DENTAL ENGINEERING LABORATORIES, LLC
Model
TFRK-SET+
Device description
The File Retrieval Kit w/ Satelec Ultrasonic Tips and Loop+
Published
2022-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYDEndodontic Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYDEndodontic KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001745628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001745628008500017456288500017456280850001745628

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
026444360
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
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
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
10850001745700PB Access90000062022-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001745635Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2022-08-22
M75240473APP0STRADIS HEALTHCARESTRADIS MEDICAL, LLCNYD2022-03-21
00850001745000Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00850001745017Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00085000174500Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
M75240473APP1STRADISSTRADIS MEDICAL, LLCNYD2016-05-05