FDA.reportPublic FDA data

Dental Engineering Lab-TFRK

Primary DI
00850001745109
Brand
Dental Engineering Lab-TFRK
Company
DENTAL ENGINEERING LABORATORIES, LLC
Model
TFRK-ME
Catalog number
TFRK-ME
Device description
Micro-Explorer
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
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001745109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001745109008500017451098500017451090850001745109

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic spreaderA hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. 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
G879102124H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-23
G8791021380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-23
G8791021190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021196L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102131H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102132H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102133H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102134H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102135H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102136H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
00887919683902Brasseler USAPeter Brasseler Holdings, LLCEKB2026-07-13
08800017902470FriendoDXM CO., LTDEKB2026-07-13
08800017902487Gutta EasyDXM CO., LTDEKB2026-07-13
08800017902494Gutta EasyDXM CO., LTDEKB2026-07-13
00850083275686Intrace USAPILOTIS TECH LLCEKB2026-07-03
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010027HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12