FDA.reportPublic FDA data

OSSEOTITE® CERTAIN®

Primary DI
00844868005001
Brand
OSSEOTITE® CERTAIN®
Company
BIOMET 3I, LLC
Model
IFNT410
Device description
FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM
Published
2015-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844868005001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868005001008448680050018448680050010844868005001

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)342-54543iPBG-CS@biomet.com

Regulatory Flags#

DUNS number
186127825
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844868051824Single Patient ACT® Twist DrillSPACT20152025-12-18
00844868051831Single Patient ACT® Twist Drill, 2mmD x 10mmLSPACT20102025-12-18
00844868051848Single Patient ACT® Twist DrillSPACT20202025-12-18
00844868051855Single Patient ACT® Twist DrillSPACT206S2025-12-18
00844868051862Single Patient ACT® Twist DrillSPACT27102025-12-18
00844868051879Single Patient ACT® Twist DrillSPACT27152025-12-18
00844868051886Single Patient ACT® Twist DrillSPACT27202025-12-18
00844868051893Single Patient ACT® Twist DrillSPACT30102025-12-18
00844868051909Single Patient ACT® Twist DrillSPACT30152025-12-18
00844868051916Single Patient ACT® Twist DrillSPACT30202025-12-18
00844868051923Single Patient ACT® Twist DrillSPACT31102025-12-18
00844868051930Single Patient ACT® Twist DrillSPACT31152025-12-18
00844868051947Single Patient ACT® Twist DrillSPACT31202025-12-18
00844868051954Single Patient ACT® Twist DrillSPACT32102025-12-18
00844868051961Single Patient ACT® Twist DrillSPACT32152025-12-18
00844868051978Single Patient ACT® Twist DrillSPACT32202025-12-18
00844868051985Single Patient ACT® Twist DrillSPACT326S2025-12-18
00844868051992Single Patient ACT® Twist DrillSPACT38102025-12-18
00844868052005Single Patient ACT® Twist DrillSPACT38152025-12-18
00844868052012Single Patient ACT® Twist DrillSPACT38202025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135989LOCATORZest Anchors, LLCDZE2026-05-22
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20