FDA.reportPublic FDA data

Medicon

Primary DI
04046826179656
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
335.00.23
Catalog number
335.00.23
Device description
dental explorer fig 23
Published
2020-09-24
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
04046826179656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826179656040468261796564046826179656

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags#

DUNS number
315492330
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
04046826346812Medicon68.86.89A68.86.89A2026-06-25
04046826416676Medicon68.87.28A68.87.28A2026-06-25
04046826542337Medicon68.86.4868.86.482026-06-25
04046826543655Medicon68.86.4968.86.492026-06-25
04046826552473Medicon68.93.4168.93.412026-06-25
04046826486631Stern-a-Fix Sternal Closure System54.81.0854.81.082026-06-24
04046826442842Medicon Tray906.91.16906.91.162026-06-22
04046826485429MediExpand Cervical Expandable VBR System405.06.38405.06.382026-06-22
04046826485436MediExpand Cervical Expandable VBR System405.06.58405.06.582026-06-22
04046826486020Medicon Tray906.91.36906.91.362026-06-22
04046826002572Medicon03.05.1703.05.172026-04-30
04046826020507Medicon14.06.1214.06.122026-04-30
04046826023331Medicon15.70.1415.70.142026-04-30
04046826023362Medicon15.71.1415.71.142026-04-30
04046826050849Medicon47.30.1347.30.132026-04-30
04046826063764Medicon51.99.5051.99.502017-05-31
04046826032807Medicon24.26.1224.26.122026-04-13
04046826531508Medicon68.94.70A68.94.70A2026-04-02
04046826531522Medicon68.94.72A68.94.72A2026-04-02
04046826531539Medicon68.94.76A68.94.76A2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889950010034HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010041HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010058HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010799HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010805HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010812HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010829HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010836HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010843HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010850HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010867HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010874HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12