FDA.reportPublic FDA data

Delivery Unit

Primary DI
07899581343414
Brand
Delivery Unit
Company
Alliage S/A Indústrias Médico Odontológica
Model
Syncrus G8 FE
Catalog number
41000008349
Device description
Delivery Unit Syncrus G8 FE
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863021000CM-II, CM-I WATER UNITSds Dental, Inc.1986-10-01EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899581343414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899581343414078995813434147899581343414

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898231451
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899581339639Dental CT Scanner AXRAXR90160000040582023-10-18
07899581342707Delivery UnitSyncrus G2410000082932025-12-31
07899581342844Delivery UnitSyncrus G3410000083072025-12-31
07899581343186Delivery UnitSyncrus G3 H410000083092025-12-31
07899581343599Delivery UnitSyncrus G8 HE410000083502025-12-31
07899581343834Water UnitSyncrus G2410000081882025-12-31
07899581343933Water UnitSyncrus G2410000081842025-08-01
07899581343957Water UnitSyncrus G3410000081992025-08-01
07899581344015Water UnitSyncrus G4A410000082052025-08-01
07899581340925Dental ChairSyncrus G2410000081562025-07-25
07899581337437EAGLE X-RAYAXR60 S160000034952024-02-26
07899581340703EAGLE X-RAYAXR65 S160000043752024-02-26
07899581340642Dental CT Scanner AXRAXR120160000042552024-02-23
07899581340659Dental CT Scanner AXRAXR120160000042562024-02-23
07899581340734SXR / SaevoAXR90 B160000043702024-02-23
07899581340741SXR / SaevoAXR120 B160000043712024-02-23
07899581340758SXR / SaevoAXR90 B160000043772024-02-23
07899581340765SXR / SaevoAXR90 B160000043782024-02-23
07899581340772SXR / SaevoAXR120 B160000043792024-02-23
07899581340789SXR / SaevoAXR120 B160000043802024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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