FDA.reportPublic FDA data

Abutment Fixation Screw Extra Short

Primary DI
00841307129489
Brand
Abutment Fixation Screw Extra Short
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
1000-01S
Catalog number
1000-01S
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K061319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061319000SPECTRA SYSTEMImplant Direct, LLC2006-09-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307129486PrimaryGS10
00841307129489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084130712948610841307129486
00841307129489008413071294898413071294890841307129489

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.

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
2
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoDA6530-61SDA6530-61S2025-10-31
10841307123644Surgical Kit Grommet - Large (2pk)SKG-L2017-06-23
10841307135791Simply Iconic™ / InterActive™ Healing Collar6530-176530-172026-01-05
10841307135807Simply Iconic™ / InterActive™ Healing Collar6530-17N6530-17N2026-01-05
10841307135814Simply Iconic™ / InterActive™ Healing Collar6534-176534-172026-01-05
10841307135821Simply Iconic™ / InterActive™ Healing Collar6534-17N6534-17N2026-01-05
10841307135838Simply Iconic™ / InterActive™ Healing Collar6534-17W6534-17W2026-01-05
10841307135340Legacy™ DIRECTarch™ 3.0 MUA Replacement ScrewDA1000-20SDA1000-20S2025-10-31
10841307135357Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.0mmL CollarDA8730-61SDA8730-61S2025-10-31
10841307135364Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 2.0mmL CollarDA8730-62SDA8730-62S2025-10-31
10841307135371Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 3.0mmL CollarDA8730-63SDA8730-63S2025-10-31
10841307135388Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 4.0mmL CollarDA8730-64SDA8730-64S2025-10-31
10841307135395Legacy™ DIRECTarch™ 3.0mmD Platform Straight MUA 5.0mmL CollarDA8730-65SDA8730-65S2025-10-31
10841307135401Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 1.0mmL CollarDA8730-61-17SDA8730-61-17S2025-10-31
10841307135418Legacy™ DIRECTarch™ 3.0mmD Platform 17° MUA 2.0mmL CollarDA8730-62-17SDA8730-62-17S2025-10-31
10841307135425Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 1.0mmL CollarDA8730-61-30SDA8730-61-30S2025-10-31
10841307135432Legacy™ DIRECTarch™ 3.0mmD Platform 30° MUA 2.0mmL CollarDA8730-62-30SDA8730-62-30S2025-10-31
10841307135845DIRECTarch™ Fiducial Marker 6mm - 4 PackDA-Marker6-4DA-Marker6-42025-10-31
10841307135852DIRECTarch™ Fiducial Marker 8mm - 4 PackDA-Marker8-4DA-Marker8-42025-10-31
10841307135449Legacy™ DIRECTarch™ 3.5 MUA Replacement ScrewDA1000-01SGDA1000-01SG2025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24
00842092129210PreatPreat CorporationNHA2022-10-24
07630031717757Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic CopingInstitut Straumann AGNHA2022-04-14
07630031701565Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701572Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701602Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701619Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701626Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701633Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
07630031701640Straumann Variobase Abutment / IPS e.max CAD restorationsInstitut Straumann AGNHA2019-07-18
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
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EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
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