FDA.reportPublic FDA data

NA

Primary DI
ETDG1620682
Brand
NA
Company
medmix Deutschland GmbH
Model
27G 0.4 x 25 mm, Luer Lock, double side vent, clos
Catalog number
162068
Device description
Sterile Irrigation Needles are used specifically for irrigation of the root canal of a tooth during an endodontic procedure and irrigation of periodontal pockets.Sterile endo irrigation needles are slender, hollow, tubular, metal instruments with a blunt tip. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. Endo irrigation needles are not designed for injection. This is a single-use device.
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ETDG1620682PrimaryHIBCC0
ETDG162068Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.

Regulatory Flags#

DUNS number
314320603
Device count
40
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ETDG1867772NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1867772024-10-01
ETDG1867782NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1867782024-10-01
ETDG1867792NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1867792024-10-01
ETDG1867802NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1867802024-10-01
ETDG186777NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1867772024-10-01
ETDG186778NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1867782024-10-01
ETDG186779NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1867792024-10-01
ETDG186780NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1867802024-10-01
ETDG1620622NA14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub1620622023-01-25
ETDG1620632NA16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub1620632023-01-25
ETDG1620642NA18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub1620642023-01-25
ETDG1620652NA20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub1620652023-01-25
ETDG1620542NA27G 0.4 x 32 mm, Luer Lock, single apical side ven1620542024-09-15
ETDG1620552NA30G 0.3 x 32 mm, Luer Lock, single apical side ven1620652024-09-15
ETDG162054NA27G 0.4 x 32 mm, Luer Lock, single apical side ven1620542024-09-15
ETDG162065NA30G 0.3 x 32 mm, Luer Lock, single apical side ven1620652024-09-15
ETDG1620662NA23G 0.6 x 25 mm, Luer Lock, double side vent, clos1620662023-01-26
ETDG1620672NA25G 0.5 x 25 mm, Luer Lock, double side vent, clos1620672023-01-26
ETDG1620692NA30G 0.3 x 25 mm, Luer Lock, double side vent, clos1620692023-01-26
ETDG1665842NA30G 0.3 x 25 mm, short, RW (regular wall), hub dar1665842023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29