FDA.reportPublic FDA data

Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL Co

Primary DI
10841307135647
Brand
Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL Co
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
DA6530-61S
Catalog number
DA6530-61S
Published
2025-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307135647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130713564710841307135647

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.

Contacts#

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

Regulatory Flags#

DUNS number
868856969
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
false
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
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
10841307135791Simply Iconic™ / InterActive™ Healing Collar6530-176530-172026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494378plant Implant System8dent Inc.NHA2026-10-16
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088000968496428plant Implant System8dent Inc.NHA2026-10-16
088000968496738plant Implant System8dent Inc.NHA2026-10-16
088000968499498plant Implant System8dent Inc.NHA2026-10-16
088000968499638plant Implant System8dent Inc.NHA2026-10-16
088000968501438plant Implant System8dent Inc.NHA2026-10-16
088000968501508plant Implant System8dent Inc.NHA2026-10-16
088000968501678plant Implant System8dent Inc.NHA2026-10-16
088000968501818plant Implant System8dent Inc.NHA2026-10-16
088000968501988plant Implant System8dent Inc.NHA2026-10-16
088000968513248plant Implant System8dent Inc.NHA2026-10-16
088000968513318plant Implant System8dent Inc.NHA2026-10-16
088000968513488plant Implant System8dent Inc.NHA2026-10-16
088000968513558plant Implant System8dent Inc.NHA2026-10-16
088000968513628plant Implant System8dent Inc.NHA2026-10-16
088000968513798plant Implant System8dent Inc.NHA2026-10-16
088000968513868plant Implant System8dent Inc.NHA2026-10-16
088000968513938plant Implant System8dent Inc.NHA2026-10-16
088000968514308plant Implant System8dent Inc.NHA2026-10-16
088000968514478plant Implant System8dent Inc.NHA2026-10-16
088000968514548plant Implant System8dent Inc.NHA2026-10-16
088000968515088plant Implant System8dent Inc.NHA2026-10-16
088000968515918plant Implant System8dent Inc.NHA2026-10-16
088000968516458plant Implant System8dent Inc.NHA2026-10-16
088000968516528plant Implant System8dent Inc.NHA2026-10-16
088000968516698plant Implant System8dent Inc.NHA2026-10-16
088000968581328plant Implant System8dent Inc.NHA2026-10-16
088000968586518plant Implant System8dent Inc.NHA2026-10-16
088000968586688plant Implant System8dent Inc.NHA2026-10-16