FDA.report

EK Bite Impression Coping

Primary DI
00810019247644
Brand
EK Bite Impression Coping
Company
HIOSSEN, INC.
Model
EKBIC4440
Published
2022-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810019247644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019247644008100192476448100192476440810019247644

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
796083090
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
00810125998652EK MULTI ANGLED ABUTMENTEK17MA4850TH2026-02-04
00810125998669 EK 30° Multi Angled abutment EK30MA4830TH2026-02-04
00810125998676 EK 30° Multi Angled abutment EK30MA4840TH2026-02-04
00810125998683 EK 30° Multi Angled abutment EK30MA4850TH2026-02-04
00810126043153SM7 US ( Complete Set )Y1500891U2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceCA130300072026-01-09
00810126043245ETIII SA (Ø3.2mm) Pre-mountedAET3M3008S2025-09-29
00810126043481ET III Fixture NH Regular Pre-MountedAET3R4010B2025-09-29
00810126043504ET III Fixture NH Regular Pre-MountedAET3R4011B2025-09-29
00810126043511ET III Fixture SA Regular Pre-MountedAET3R4011S2025-09-29
00810126043528ET III Fixture NH Regular Pre-MountedAET3R4013B2025-09-29
00810126043580ET III Fixture SA Regular Pre-MountedAET3R4507S2025-09-29
00810126043597ET III Fixture NH Regular Pre-MountedAET3R4508B2025-09-29
00810126043603ET III Fixture SA Regular Pre-MountedAET3R4508S2025-09-29
00810126043610ET III Fixture NH Regular Pre-MountedAET3R4510B2025-09-29
00810126043627ET III Fixture SA Regular Pre-MountedAET3R4510S2025-09-29
00810126043634ET III Fixture NH Regular Pre-MountedAET3R4511B2025-09-29
00810126043641ET III Fixture SA Regular Pre-MountedAET3R4511S2025-09-29
00810126043658ET III Fixture NH Regular Pre-MountedAET3R4513B2025-09-29
00810126043665ET III Fixture SA Regular Pre-MountedAET3R4513S2025-09-29

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08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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