FDA.report

Implantium, Superline

Primary DI
08809691362945
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
TS1323W-A2
Catalog number
TS1323W-A2
Device description
Crown, Preformed
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
true

Related Records

Contact Domains

Product Codes

CodeName
ELZCROWN, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809691362945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809691362945088096913629458809691362945

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

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
true

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