FDA.reportPublic FDA data

RePlant® Multi-Unit Abutment

Primary DI
10841307126942
Brand
RePlant® Multi-Unit Abutment
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
6060-64
Catalog number
6060-64
Published
2021-04-12
Public version status
Update
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
K081396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081396000SWISSPLANT DENTAL IMPLANT SYSTEMImplant Direct, LLC2009-01-14NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307126942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130712694210841307126942

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
10841307136378Simply Iconic™ Implant675206NP675206NP2026-10-26
10841307136385Simply Iconic™ Implant675208NP675208NP2026-10-26
10841307136392Simply Iconic™ Implant675210NP675210NP2026-10-26
10841307136408Simply Iconic™ Implant675211NP675211NP2026-10-26
10841307136415Simply Iconic™ Implant675213NP675213NP2026-10-26
10841307135883Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewDA1000-20S-AUDA1000-20S-AU2026-10-20
10841307135890Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarDA8730-61S-AUDA8730-61S-AU2026-10-20
10841307135906Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarDA8730-62S-AUDA8730-62S-AU2026-10-20
10841307135913Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarDA8730-63S-AUDA8730-63S-AU2026-10-20
10841307135920Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarDA8730-64S-AUDA8730-64S-AU2026-10-20
10841307135937Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarDA8730-65S-AUDA8730-65S-AU2026-10-20
10841307135944Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarDA8730-61-17S-AUDA8730-61-17S-AU2026-10-20
10841307135951Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarDA8730-62-17S-AUDA8730-62-17S-AU2026-10-20
10841307135968Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarDA8730-61-30S-AUDA8730-61-30S-AU2026-10-20
10841307135975Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarDA8730-62-30S-AUDA8730-62-30S-AU2026-10-20
10841307135982Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewDA1000-01SG-AUDA1000-01SG-AU2026-10-20
10841307135999Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 1.0mmL CollarDA1000-01SG-AUDA8735-61S-AU2026-10-20
10841307136002Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 2.0mmL CollarDA8735-62S-AUDA8735-62S-AU2026-10-20
10841307136019Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 3.0mmL CollarDA8735-63S-AUDA8735-63S-AU2026-10-20
10841307136026Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 4.0mmL CollarDA8735-64S-AUDA8735-64S-AU2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23