FDA.reportPublic FDA data

Implantium, Superline

Primary DI
08809162705189
Brand
Implantium, Superline
Company
Dentium Co., Ltd.
Model
XMF28H
Catalog number
XMF28H
Device description
Accessories, Implant, Dental, Endosseous
Published
2020-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECTDRIVER, BAND, ORTHODONTIC
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECTDriver, Band, OrthodonticDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809162705189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809162705189088091627051898809162705189

GMDN Terms#

Term, Definition table
TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(714)226-0229cs@dentiumusa.com

Regulatory Flags#

DUNS number
689514395
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809544909761Implantium, SuperlineWFFD3606WFFD36062026-05-15
08809544909778Implantium, SuperlineWFFD3608WFFD36082026-05-15
08809544909785Implantium, SuperlineWFFD3610WFFD36102026-05-15
08809544909792Implantium, SuperlineWFFD3612WFFD36122026-05-15
08809544909808Implantium, SuperlineWFFD4006WFFD40062026-05-15
08809544909815Implantium, SuperlineWFFD4008WFFD40082026-05-15
08809544909822Implantium, SuperlineWFFD4010WFFD40102026-05-15
08809544909839Implantium, SuperlineWFFD4012WFFD40122026-05-15
08809544909846Implantium, SuperlineWFFD4506WFFD45062026-05-15
08809544909853Implantium, SuperlineWFFD4508WFFD45082026-05-15
08809544909860Implantium, SuperlineWFFD4510WFFD45102026-05-15
08809544909877Implantium, SuperlineWFFD4512WFFD45122026-05-15
08809544909884Implantium, SuperlineWFFD5006WFFD50062026-05-15
08809544909891Implantium, SuperlineWFFD5008WFFD50082026-05-15
08809544909907Implantium, SuperlineWFFD5010WFFD50102026-05-15
08809544909914Implantium, SuperlineWFFD5012WFFD50122026-05-15
08809544909921Implantium, SuperlineWFTP35WFTP352026-05-15
08809544909938Implantium, SuperlineWFTP45WFTP452026-05-15
08809544909945Implantium, SuperlineWFFL35WFFL352026-05-15
08809544909952Implantium, SuperlineWFFL45WFFL452026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03