FDA.reportPublic FDA data

Eighteeth

Primary DI
06941877829872
Brand
Eighteeth
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
Orion D
Catalog number
7680178
Device description
The Screwdriver is used for installing and removing the scan body.. The Screwdriver must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel.
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941877829872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941877829872069418778298726941877829872

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
560366787
Device count
1
Premarket exempt
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
06941877830076EighteethE-FLEX REC-20151831042026-05-26
06941877830083EighteethE-FLEX REC-20251831052026-05-26
06941877829704EighteethFindPex61801532026-05-07
06941877829728EighteethOrion Kit-M1.476801632026-05-07
06941877829735EighteethOrion Kit-M1.676801642026-05-07
06941877829742EighteethOrion Kit-M1.876801652026-05-07
06941877829759EighteethOrion SC-M1.476801662026-05-07
06941877829766EighteethOrion SC-M1.676801672026-05-07
06941877829773EighteethOrion SC-M1.876801682026-05-07
06941877829780EighteethOrion SS-M1.476801692026-05-07
06941877829797EighteethOrion SM-M1.476801702026-05-07
06941877829803EighteethOrion SL-M1.476801712026-05-07
06941877829810EighteethOrion SS-M1.676801722026-05-07
06941877829827EighteethOrion SM-M1.676801732026-05-07
06941877829834EighteethOrion SL-M1.676801742026-05-07
06941877829841EighteethOrion SS-M1.876801752026-05-07
06941877829858EighteethOrion SM-M1.876801762026-05-07
06941877829865EighteethOrion SL-M1.876801772026-05-07
06941877825287EighteethibT5050T50809902026-05-06
06941877825294EighteethibT7235T50809912026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08