FDA.reportPublic FDA data

N/A

Primary DI
06009544047681
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
HA-DCR5-2
Device description
Abutment Healing DCR5 Ø5.5x2
Published
2024-08-21
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
K163060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163060000Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.2017-06-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544047681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544047681060095440476816009544047681

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
636239584
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009544030287N/AIC-K4262026-10-01
06009544052401N/ACMC12026-10-01
06009544052418N/ACMCW12026-10-01
06009544052425N/ACNB5-152026-10-01
06009544052432N/ACP2026-10-01
06009544052517N/ACMC22026-10-01
06009544052524N/ACMC2L2026-10-01
06009544052531N/ACMCW22026-10-01
06009544052548N/ACMC-ZG-22026-10-01
06009544052555N/ACSD42026-10-01
06009544052630N/AIC-DC32026-10-01
06009544052647N/AIC-DC3-W2026-10-01
06009544052654N/AIC-DC42026-10-01
06009544052661N/AIC-DC4-W2026-10-01
06009544052678N/AIC-DC52026-10-01
06009544052685N/AIC-DC5-W2026-10-01
06009544052692N/AIC-DCR52026-10-01
06009544052708N/AIC-K4062026-10-01
06009544052715N/AIC-K4162026-10-01
06009544052722N/AIC-K5062026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014894Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014900Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014917Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014924Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014948Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014955Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014962Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014979Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014986Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06