FDA.reportPublic FDA data

8 MM ULTRA TOOTH IMPLANT

Primary DI
00852550007202
Brand
8 MM ULTRA TOOTH IMPLANT
Company
Bio-Dent, Inc.
Model
3908UT
Published
2016-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K981141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981141000SARGON IMMEDIATE LOAD IMPLANT, MODEL DSargon Ent., Inc.1999-06-23DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852550007202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852550007202008525500072028525500072020852550007202

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017725036
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008525500071658mm ULTRA TOOTH SOLID WIDE IMPLANT3908UTW2016-12-22
0085255000717210 MM ULTRA TOOTH SOLID WIDE IMPLANT3910 UTW2016-12-22
0085255000718913 MM ULTRA TOOTH SOLID WIDE IMPLANT3913 UTW2016-12-22
0085255000719616 MM ULTRA TOOTH SOLID WIDE IMPLANT3916UTW2016-12-22
0085255000721910 MM ULTRA TOOTH IMPLANT3910UT2016-12-22
0085255000722613 MM ULTRA TOOTH IMPLANT3913UT2016-12-22
0085255000723316 MM ULTRA TOOTH IMPLANT3916UT2016-12-22
008525500072578 MM IC STD NON-EXPANDABLE IMPLANT3808I2016-12-22
0085255000726410 MM IC STD NON-EXPANDABLE IMPLANT3810I2016-12-22
0085255000727113 MM IC STD NON-EXPANDABLE IMPLANT3813I2016-12-22
0085255000728816 MM IC STD NON-EXPANDABLE IMPLANT3816I2016-12-22
008525500072958 MM IC SMALL DIAMETER NON-EXPANDABLE IMPLANT3808ISD2016-12-22
0085255000730110 MM IC SMALL DIAMETER NON-EXPANDABLE IMPLANT3810ISD2016-12-22
0085255000731813 MM IC SMALL DIAMETER NON-EXPANDABLE IMPLANT3813ISD2016-12-22
0085255000732516 MM IC SMALL DIAMETER NON-EXPANDABLE IMPLANT3816ISD2016-12-22
008525500073328 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT3808IWD2016-12-22
0085255000734910 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT3810IWD2016-12-22
0085255000735613 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT3813IWD2016-12-22
0085255000736316 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT3816IWD2016-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
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08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
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08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26