FDA.reportPublic FDA data

Abutment Screw

Primary DI
07899995279668
Brand
Abutment Screw
Company
Sin Sistema de Implante Nacional S/A
Model
PRH 30 PACK4
Catalog number
PRH 30 PACK4
Device description
RETAINING SCREW HEXAGONAL 3
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K051859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051859000SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEMSin Sistema DE Implante Nacional Ltda2005-09-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995279668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995279668078999952796687899995279668

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

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
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23
07899995243812DRIVER RATCHET HEX1.4 LONG ANG.CCH 1430ACCH 1430A2025-12-23
07899995243829DRIVER RATCHET HEX1.4 MEDIUM ANG.CCH 1424ACCH 1424A2025-12-23
07899995243836DRIVER RATCHET HEX1.4 SHORT ANG.CCH 1420ACCH 1420A2025-12-23
07899995243843DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.CTH 1437ACTH 1437A2025-12-23
07899995243850DRIVER HANDPIECE HEX.1.4MM LONG ANG.CTH 1430ACTH 1430A2025-12-23
07899995243874DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.CTH 1424ACTH 1424A2025-12-23
07899995243881DRIVER HANDPIECE HEX.1.4MM SHORT ANG.CTH 1420ACTH 1420A2025-12-23
07899995240507DIRECTION INDICATOR ANGLED 52°IDA 52IDA 522025-11-26
07899995241108BioHorizonsZPK4500ZPK45002025-11-25
07899995243140BioHorizonsZPMDZPMD2025-11-25
07899995243157BioHorizonsZDPZDP2025-11-25
07899995243164BioHorizonsSTW80STW802025-11-25
07899995243225BioHorizonsHD050RHD050R2025-11-25
07899995243232BioHorizonsHD050MHD050M2025-11-25
07899995243263BioHorizonsHD050HHD050H2025-11-25
07899995243270BioHorizonsCRTRY60CRTRY602025-11-25
07899995243287BioHorizonsCRTRY52CRTRY522025-11-25
07899995243294BioHorizonsCRTRY45CRTRY452025-11-25
07899995243317BioHorizonsCRIDRSCRIDRS2025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842092174999PreatPreat CorporationNHA2026-06-09
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04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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