FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436921865
Brand
KOHDENT
Company
Kohler Medizintechnik GmbH
Model
6904
Catalog number
6904
Device description
SYNDESMOTOME No. 29 -APICAL-handle- - hollow inside -
Published
2021-08-30
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
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436921865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436921865042514369218654251436921865

GMDN Terms#

Term, Definition table
TermDefinition
SyndesmotomeA hand-held, dental, surgical instrument designed for cutting desmodontal fibres and for detaching the alveolodental ligaments (the fibrous connective tissue surrounding the root of a tooth that separates it from and attaches it to the alveolar bone). It is typically made of high-grade stainless steel and has a long shaft with a handle at the proximal end and an angled scythe-like or knife-like blade at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497771649990info@kohler-medizintechnik.de

Regulatory Flags#

DUNS number
344386737
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436919084Kohler6414-CC2026-04-23
04251436943850Kohler83142026-04-23
04251436909030KOHLER451645162026-03-12
04251436934155KOHLER451645162026-03-12
04251436931086KOHLER955795572026-03-12
04251436943805KOHLER842884282026-03-12
04251436943812KOHLER8461-CC8461-CC2026-03-12
04251436943836KOHLER8401-N8401-N2026-03-12
04251436943843KOHLER330833082026-03-12
04251436907746KOHDENT430643062021-08-30
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22

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Primary DI, Brand, Company table
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G879LX3CFG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G879LX3DCG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
D955BDT11Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT21Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT31Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT61Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT71Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT81Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT91Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE461Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE571Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE581Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE77RW1Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
G879LXB50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-25
G879103420TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879106049TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
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G879101067S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
00190776408688MillenniumAvalign Technologies, Inc.EMJ2026-08-03