FDA.reportPublic FDA data

Legacy™ Plastic Engaging Temporary Abutment-Concave Profile

Primary DI
10841307134084
Brand
Legacy™ Plastic Engaging Temporary Abutment-Concave Profile
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
8735-47
Catalog number
8735-47
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K130572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130572000INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC2013-12-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307134084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130713408410841307134084

GMDN Terms#

Term, Definition table
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#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-649-6425customerservice@implantdirect.com

Regulatory Flags#

DUNS number
868856969
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841307130284Ball Abutment Housing1000-811000-812024-03-12
10841307130291Ball Abutment Nylon Liner1000-821000-822024-03-12
10841307120100Ball Abutment Housing & Liner1000-881000-882015-12-29
10841307122463DirectOss™DXCA102005DXCA1020052016-08-31
10841307122470DirectOss™DXCA102010DXCA1020102016-08-31
10841307122487DirectOss™DXCA102015SDXCA102015S2016-08-31
10841307122494DirectOss™DXCA102020DXCA1020202016-08-31
10841307122500DirectOss™DXCA102025DXCA1020252016-08-31
10841307122517DirectOss™DXCA251005DXCA2510052016-08-31
10841307122524DirectOss™DXCA251005SDXCA251005S2016-08-31
10841307122531DirectOss™DXCA251010DXCA2510102016-08-31
10841307122548DirectOss™DXCA251010SDXCA251010S2016-08-31
10841307122555DirectOss™DXCA251020DXCA2510202016-08-31
10841307122562DirectOss™DXCA251025DXCA2510252016-08-31
10841307122579DirectOss™DXCA251025SDXCA251025S2016-08-31
10841307119234Stainless Steel RachetRR2015-12-29
10841307123644Surgical Kit Grommet - Large (2pk)SKG-LSKG-L2017-06-23
10841307123651Surgical Kit Grommet - Medium (2pk)SKG-MSKG-M2017-06-23
10841307123668Surgical Kit Grommet - Small (2pk)SKG-SSKG-S2017-06-23
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoDA6530-61SDA6530-61S2025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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