FDA.reportPublic FDA data

8 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT

Primary DI
00852550007332
Brand
8 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT
Company
Bio-Dent, Inc.
Model
3808IWD
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
K082573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082573000SARGON NON-EXPANDABLE DENTAL IMPLANTSargon Ent., Inc.2010-07-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852550007332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852550007332008525500073328525500073320852550007332

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
008525500072028 MM ULTRA TOOTH IMPLANT3908UT2016-12-22
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
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
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28