FDA.report

BioHorizons

Primary DI
00847236002909
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
292-000
Device description
One-piece 3.0 Implant Analog
Published
2021-06-22
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
00847236002909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236002909008472360029098472360029090847236002909

GMDN Terms

TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

Sterilization Methods

Method

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
false

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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08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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