FDA.reportPublic FDA data

BioHorizons

Primary DI
07899995245229
Brand
BioHorizons
Company
Sin Sistema de Implante Nacional S/A
Model
CR45MU25
Catalog number
CR45MU25
Device description
CONICAL 45 DEG MUA 2.5MM GH REGULAR
Published
2025-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251129000S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda2025-11-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995245229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995245229078999952452297899995245229

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
904569092
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BPFCM 01BPFCM 01B2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD APFCM 01APFCM 01A2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BPFMT 01BPFMT 01B2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD APFMT 01APFMT 01A2026-07-22
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGCTA 01ELCTA 01EL2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGCTA 01LCTA 01L2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMCTA 01MCTA 01M2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGCCA 01ELCCA 01EL2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGCCA 01LCCA 01L2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMCCA 01MCCA 01M2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTCCA 01CCCA 01C2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTCCA 01ECCCA 01EC2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGCCER 18LCCER 18L2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMCCER 18MCCER 18M2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTCCER 18CCCER 18C2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGCCER 16LCCER 16L2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTCCER 16CCCER 16C2026-07-14
07899995235541RATCHET RETRIEVER DRIVER M1.6 MEDIUMCCER 16MCCER 16M2026-06-23
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
06009544052036N/ASOUTHERN IMPLANTS (PTY) LTDNHA2026-09-30
00840481138492LOCATOR, compatible with Nobel BiocareZest Anchors, LLCNHA2026-09-29
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29