FDA.reportPublic FDA data

Stratos 300 Grundausstattung

Primary DI
DVIV576821BN1
Brand
Stratos 300 Grundausstattung
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
576821BN
Catalog number
576821BN
Device description
Stratos 300 Basic Model
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJPARTICULATORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV576821BN1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
448015938
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208570830Adhese 2 100768338WW768338WW2026-07-22
07615208474398Clinical Auxiliary (no MD)7608167608162026-07-14
07615208592634Ivotion Dent7711817711812026-07-09
07615208592689Ivotion Dent7711827711822026-07-09
07615208592696Ivotion Dent7711857711852026-07-09
07615208592702Ivotion Dent7711867711862026-07-09
07615208592719Ivotion Dent7711877711872026-07-09
07615208585728Ivotion Base7712057712052026-07-08
07615208585735Ivotion7712077712072026-07-08
07615208585742Ivotion7712087712082026-07-08
07615208585759Ivotion7712097712092026-07-08
07615208585766Ivotion7712107712102026-07-08
07615208585773Ivotion7712117712112026-07-08
07615208585780Ivotion7712127712122026-07-08
07615208585797Ivotion7712137712132026-07-08
07615208585803Ivotion7712147712142026-07-08
07615208585810Ivotion7712157712152026-07-08
07615208585827Ivotion7712167712162026-07-08
07615208585834Ivotion7712177712172026-07-08
07615208585841Ivotion7712187712182026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040342160MA2340 W/STRAPSWHIP-MIX CORPORATIONEJP2025-09-11
00348783005813W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005820W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005837W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005844W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005851W.O.W.™ 2PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
D040200113770Denar Mark 310 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200113780Denar Mark 320 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200114080Denar Mark 330 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
08800075601490OSUNG MNDOSUNG MND Co., Ltd.EJP2024-02-22
08964003163570Doctor NiceB. Ali ImpexEJP2024-01-29
08964003163587ECCOB. Ali ImpexEJP2024-01-29
E1997592331ArticulatorCandulor AGEJP2023-10-18
00816063020677iTero Articulator KitAlign Technology, Inc.EJP2021-06-04
E23550700HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550710HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550730HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550740HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550750HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550760HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
D0400033020001Hanau 96 H2 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400098560001Hanau-Mate Non-Adjustable ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400108850001Hanau Wide-Vue ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141020001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141160001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143000001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143090001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400145030001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400224614640 Q ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400226712240 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22