FDA.report

BioHorizons

Primary DI
00847236017408
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
CBD-42
Device description
Tapered Crestal Bone Drill, Green, 4.2mm
Published
2021-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847236017408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236017408008472360174088472360174080847236017408

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
967279910
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00847236027797BioHorizonsCNTE0TCNTE0T2026-02-26
00847236027803BioHorizonsCNTE2TCNTE2T2026-02-26
00847236027810BioHorizonsCNTE3SCNTE3S2026-02-26
00847236027827BioHorizonsCNTE3TCNTE3T2026-02-26
00847236027834BioHorizonsCNTE4SCNTE4S2026-02-26
00847236027841BioHorizonsCNTE4TCNTE4T2026-02-26
00847236027858BioHorizonsCNTEA3CNTEA32026-02-26
00847236027865BioHorizonsCNTEA4CNTEA42026-02-26
00847236027872BioHorizonsCNTNA3CNTNA32026-02-26
00847236027889BioHorizonsCNTNA4CNTNA42026-02-26
00847236027896BioHorizonsCRTE3SCRTE3S2026-02-26
00847236027902BioHorizonsCRTE3TCRTE3T2026-02-26
00847236027919BioHorizonsCRTE4SCRTE4S2026-02-26
00847236027926BioHorizonsCRTE4TCRTE4T2026-02-26
00847236027933BioHorizonsCRTEA3CRTEA32026-02-26
00847236027940BioHorizonsCRTEA4CRTEA42026-02-26
00847236027957BioHorizonsCRTNA3CRTNA32026-02-26
00847236027964BioHorizonsCRTNA4CRTNA42026-02-26
00847236027421BioHorizonsPXMUPSDPXMUPSD2025-06-12
00847236027438BioHorizonsPXMUPSD25PXMUPSD252025-06-12

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