FDA.reportPublic FDA data

Angled Abutment

Primary DI
08800023116564
Brand
Angled Abutment
Company
Cybermed Inc.
Model
CAA25AM4573ES
Published
2022-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K210039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210039000CORE1 Implant SystemCybermed, Inc.2022-01-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023116564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023116564088000231165648800023116564

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+827051187131kshwan95@cybermed.co.kr

Regulatory Flags#

DUNS number
688248447
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800023142327Link AbutmentICLAHM4041S2024-10-31
08800023142334Link AbutmentICLAHM4042S2024-10-31
08800023142341Link AbutmentICLAHM4043S2024-10-31
08800023142358Link AbutmentICLAHM4044S2024-10-31
08800023142365Link AbutmentICLAHM4061S2024-10-31
08800023142372Link AbutmentICLAHM4062S2024-10-31
08800023142389Link AbutmentICLAHM4063S2024-10-31
08800023142396Link AbutmentICLAHM4064S2024-10-31
08800023142402Link AbutmentICLAHR4541S2024-10-31
08800023142419Link AbutmentICLAHR4542S2024-10-31
08800023142426Link AbutmentICLAHR4543S2024-10-31
08800023142433Link AbutmentICLAHR4544S2024-10-31
08800023142440Link AbutmentICLAHR4561S2024-10-31
08800023142457Link AbutmentICLAHR4562S2024-10-31
08800023142464Link AbutmentICLAHR4563S2024-10-31
08800023142471Link AbutmentICLAHR4564S2024-10-31
08800023142488Link AbutmentICLAHR5541S2024-10-31
08800023142495Link AbutmentICLAHR5542S2024-10-31
08800023142501Link AbutmentICLAHR5543S2024-10-31
08800023142518Link AbutmentICLAHR5544S2024-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
08800292991923Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991930Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03