FDA.reportPublic FDA data

W.O.W.™ 2

Primary DI
00348783005851
Brand
W.O.W.™ 2
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
0072AD
Device description
WOW II POSTERIOR (AIR DAM)
Published
2024-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00348783005851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783005851003487830058513487830058510348783005851

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
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09
00348783010756Premier Jackson Original Tracheostomy Tube10343202026-06-09
00348783010770Premier Jackson Improved Tracheostomy Tube10346102026-06-09
00348783010787Premier Jackson Improved Tracheostomy Tube10346112026-06-09
00348783010794Premier Jackson Improved Tracheostomy Tube10346122026-06-09
00348783010800Premier Jackson Improved Tracheostomy Tube10346132026-06-09
00348783010817Premier Jackson Improved Tracheostomy Tube10346142026-06-09
00348783010824Premier Jackson Improved Tracheostomy Tube10346152026-06-09
00348783010831Premier Jackson Improved Tracheostomy Tube10346162026-06-09
00348783010848Premier Jackson Improved Tracheostomy Tube10346172026-06-09
00348783010855Premier Jackson Improved Tracheostomy Tube10346182026-06-09

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
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
D0400227814641 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22