FDA.reportPublic FDA data

REBORN Fixture

Primary DI
08800023151817
Brand
REBORN Fixture
Company
Cybermed Inc.
Model
IC1R5508C
Published
2024-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
08800023151817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023151817088000231518178800023151817

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04