FDA.reportPublic FDA data

Pre-milled Blank

Primary DI
08800055716329
Brand
Pre-milled Blank
Company
ARUM DENTISTRY Co., Ltd.
Model
CIHE099
Published
2026-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K242245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242245000Customized AbutmentArum Dentistry Co., Ltd.2024-11-25NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800055716329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800055716329088000557163298800055716329

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
557821945
Device count
1
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
08800265648601Cemented AbutmentCAB4555M2026-03-11
08800265640377SD Bone Level FixtureB60102026-03-10
08800055715605Pre-milled BlankCIHE0232026-03-12
08800055715612Pre-milled BlankCIHE0242026-03-12
08800055715629Pre-milled BlankCIHE0252026-03-12
08800055715636Pre-milled BlankCIHE0262026-03-12
08800055715865Pre-milled BlankCIHE0532026-03-12
08800055715872Pre-milled BlankCIHE0542026-03-12
08800055715889Pre-milled BlankCIHE0552026-03-12
08800055715896Pre-milled BlankCIHE0562026-03-12
08800055715902Pre-milled BlankCIHE0572026-03-12
08800055715919Pre-milled BlankCIHE0582026-03-12
08800055716282Pre-milled BlankCIHE0952026-03-12
08800055716299Pre-milled BlankCIHE0962026-03-12
08800055716305Pre-milled BlankCIHE0972026-03-12
08800055716312Pre-milled BlankCIHE0982026-03-12
08800055716336Pre-milled BlankCIHE1002026-03-12
08800055746128Pre-milled BlankCIHE2012026-03-12
08800055746135Pre-milled BlankCIHE2022026-03-12
08800055762067Pre-milled BlankCIHE023P2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046888EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27