FDA.reportPublic FDA data

Cemented Cylinder

Primary DI
08800049245422
Brand
Cemented Cylinder
Company
DIO Corporation
Model
ICC 48508[H]
Published
2025-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K122519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122519000DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEMDio Corporation2013-05-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800049245422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800049245422088000492454228800049245422

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631085206
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800049245330Healing CapHCI 48504[H]2025-09-19
08800049245361Healing CapHCI 65704[H]2025-09-19
08800049245460Cemented CylinderICC 48588[H]2025-09-19
08800049245507Cemented CylinderICC 60649[H]2025-09-19
08800049245545Cemented CylinderICC 65309[H]2025-09-19
08800049416884Temporary CylinderITC 480102025-09-19
08806169097729Healing CapHCI 60704[H]2025-09-19
08800049414217DIOnavi GuideGUIDE 02 A01(a,b)2025-09-18
08800049414231DIOnavi GuideGUIDE 02 A02(a,b)2025-09-18
08800049414255DIOnavi GuideGUIDE 02 A03(a,b)2025-09-18
08800049414279DIOnavi GuideGUIDE 02 A04(a,b)2025-09-18
08800049414293DIOnavi GuideGUIDE 02 A05(a,b)2025-09-18
08800049438961UF(II) Eastab CylinderESMC 4812N2025-09-18
08800049438985UF(II) Eastab CylinderESMC 4812H2025-09-18
08800049438992UF(II) Eastab Cylinder Semi FinalESMCSF 4806N2025-09-18
08800049443040UF(II) Eastab Cylinder Semi FinalESMCSF 4806H2025-09-18
08800049282892Pre-milled BarCBMC 02H2025-09-16
08800049282908Pre-milled BarCBMC 02N2025-09-16
08800049283448Pre-milled BarCBZN 012025-09-16
08800049283486Pre-milled BarCBZR 012025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
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05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
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D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26