FDA.report

Bite Impression Coping

Primary DI
08800011264307
Brand
Bite Impression Coping
Company
POINTIMPLANT Co., Ltd.
Model
OBICR7006P
Published
2025-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800011264307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800011264307088000112643078800011264307

GMDN Terms

TermDefinition
Dental precision attachment simulator/analog, single-useA device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
695333960
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800011245764Pick-Up Impression CopingPIICP48072025-07-24
08800011245771Pick-Up Impression CopingPIICP48122025-07-24
08800011245788Pick-Up Impression CopingPIICP65072025-07-24
08800011245795Pick-Up Impression CopingPIICP65122025-07-24
08800011245801Pick-Up Impression CopingPIICP4807N2025-07-24
08800011245818Pick-Up Impression CopingPIICP4812N2025-07-24
08800011245825Pick-Up Impression CopingPIICP6507N2025-07-24
08800011245832Pick-Up Impression CopingPIICP6512N2025-07-24
08800011260156Guide PinPIICTS2025-07-24
08800011260163Guide PinPIICTL2025-07-24
08800011260637Fixture MountOFMI2025-07-24
08800011260644Fixture Mount ScrewOFMIS2025-07-24
08800011260835Pick-Up Impression CopingPIIC4808P2025-07-24
08800011260842Pick-Up Impression CopingPIIC4812P2025-07-24
08800011262174Pick-Up Impression CopingPIICP4807P2025-07-24
08800011262181Pick-Up Impression CopingPIICP6507P2025-07-24
08800011262198Pick-Up Impression CopingPIICP4807NP2025-07-24
08800011262204Pick-Up Impression CopingPIICP6507NP2025-07-24
08800011262211Pick-Up Impression CopingPIICP4812NP2025-07-24
08800011262228Pick-Up Impression CopingPIICP4812P2025-07-24

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08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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