FDA.report

Taper Ultra KIT

Primary DI
08800209374467
Brand
Taper Ultra KIT
Company
Osstem Implant Co., Ltd.
Model
OULTPK
Published
2023-08-07
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
false

Related Records

Product Codes

CodeName
NYEFixture Mount Kit

Product Code Classifications

CodeDeviceSpecialtyClass
NYEFixture Mount KitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800209374467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800209374467088002093744678800209374467

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
689051793
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true

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08800271240516Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
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08800271234409OneArch KITOsstem Implant Co., Ltd.NYE2025-01-03
08800271233976OneArch KITOsstem Implant Co., Ltd.NYE2024-12-09
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08809917070050123 Straight Full KITOsstem Implant Co., Ltd.NYE2024-08-20
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