FDA.report

CERTAIN®

Primary DI
00844868007906
Brand
CERTAIN®
Company
BIOMET 3I, LLC
Model
ISHA48
Device description
CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 8MM(H)
Published
2015-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844868007906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868007906008448680079068448680079060844868007906

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Height8Millimeter

Sterilization Methods

Method

Contacts

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

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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

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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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