FDA.report

Implantium, Superline

Primary DI
08809544906678
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
DAN34D
Catalog number
DAN34D
Device description
Accessories, Implant, Dental, Endosseous
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809544906678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809544906678088095449066788809544906678

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.

Device Sizes

TypeValueUnit
Length12Millimeter
Outer Diameter4Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(714)226-0229cs@dentiumusa.com

Regulatory Flags

DUNS number
689514395
Device count
1
DM exempt
true
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

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08809544909983Implantium, SuperlineXGSFKWXGSFKW2024-10-15
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08809544907279Implantium, SuperlineXRFSXRFS2024-10-07
08809544907675NR LineGXSDD30HGXSDD30H2024-10-07
08809772433168Implantium, SuperlineDGAP08DGAP082024-02-14
08809772433175Implantium, SuperlineDGAP12DGAP122024-02-14
08809772439948Implantium, SuperlineDGAP06DGAP062024-02-14
08809772439955Implantium, SuperlineDGAP10DGAP102024-02-14
08809162708821NR LineGCMAB30RSGCMAB30RS2023-12-08

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