FDA.reportPublic FDA data

Guide Screw

Primary DI
06947600316992
Brand
Guide Screw
Company
BIO CONCEPT Co., Ltd.
Model
352950
Published
2024-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
06947600316992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947600316992069476003169926947600316992

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
527603266
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947600321811Bone Level Tapered Implant,Φ4.1mm,L18mm,No-mount318010G2025-12-05
06947600330035Bone Level Tapered Implant,Φ4.8mm,L18mm,No-mount314100G2025-12-05
06936616987739Dome Drill,Φ5.5mm, L25mm3595102025-03-25
06936616987746Dome Drill,Φ7.0mm, L25mm3595202025-03-25
06936616987753Dome Drill,Φ7.0mm, L26mm3595302025-03-25
06936616987760Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm3595402025-03-25
06936616987777Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm3595502025-03-25
06936616987784Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm3595602025-03-25
06936616987791Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm3595702025-03-25
06936616987807Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm3595802025-03-25
06936616987814Osteotome maxillary sinus elevation Drill,Φ3.3mm, L37mm3595902025-03-25
06936616987821Osteotome maxillary sinus elevation Drill,Φ3.6mm, L31mm3596002025-03-25
06936616987838Osteotome maxillary sinus elevation Drill,Φ3.6mm, L37mm3596102025-03-25
06936616987845Osteotome maxillary sinus elevation Drill,Φ3.8mm, L31mm3596202025-03-25
06936616987852Osteotome maxillary sinus elevation Drill,Φ3.8mm, L37mm3596302025-03-25
06936616987869Osteotome maxillary sinus elevation Drill,Φ4.1mm, L31mm3596402025-03-25
06936616987876Osteotome maxillary sinus elevation Drill,Φ4.1mm, L37mm3596502025-03-25
06936616987883Guide Drill,Φ2.0mm, L36mm3596602025-03-25
06936616987890Twist Drill,Φ2.0mm, L38mm3596702025-03-25
06936616987906Twist Drill,Φ2.2mm, L37mm3596802025-03-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
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EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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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
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