FDA.report

BioHorizons

Primary DI
00847236004903
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
PBTBLS
Device description
Internal 5.7mm Laser-Lok Protective Sleeve
Published
2020-10-27
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
00847236004903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236004903008472360049038472360049030847236004903

GMDN Terms

TermDefinition
Dental precision attachment fitting/adjustment toolA manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). 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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