FDA.reportPublic FDA data

BioHorizons

Primary DI
00847236015947
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
BSCSZ
Device description
Surgical Curved Scissors
Published
2021-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EGNScissors, Surgical Tissue, Dental
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1200480

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200480

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847236019037Direct MarkingGS10
00847236015947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236019037008472360190378472360190370847236019037
00847236015947008472360159478472360159470847236015947

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
967279910
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
00847236025762BioHorizonsCNODS12026-04-06
00847236025779BioHorizonsCNODS22026-04-06
00847236025786BioHorizonsCNODS32026-04-06
00847236025793BioHorizonsCNODS42026-04-06
00847236025809BioHorizonsCRODS12026-04-06
00847236025816BioHorizonsCRODS22026-04-06
00847236025823BioHorizonsCRODS32026-04-06
00847236025830BioHorizonsCRODS42026-04-06
00847236027971BioHorizonsCNIDH112026-04-01
00847236027988BioHorizonsCNIDH182026-04-01
00847236027995BioHorizonsCNIDR112026-04-01
00847236028008BioHorizonsCNIDR182026-04-01
00847236028015BioHorizonsCRIDH112026-04-01
00847236028022BioHorizonsCRIDH182026-04-01
00847236028039BioHorizonsCRIDR112026-04-01
00847236028046BioHorizonsCRIDR182026-04-01
00847236028053BioHorizonsPROID302026-04-01
00847236028060BioHorizonsPROID3342026-04-01
00847236028077BioHorizonsPROID382026-04-01
00847236028084BioHorizonsPROID422026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E896115984210SCHWERTA. Schweickhardt GmbH & Co. KGEGN2026-10-22
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
B382SD62371520Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903223060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454040Surgical DirectSurgical Direct, Inc.EGN2026-10-15
B382SD903454060Surgical DirectSurgical Direct, Inc.EGN2026-10-15
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
B382SD9030741020Surgical DirectSurgical Direct, Inc.EGN2026-10-08