FDA.reportPublic FDA data

Fixation Screw

Primary DI
00841307129557
Brand
Fixation Screw
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
1000-15
Catalog number
1000-15
Published
2024-03-12
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
10841307129554PrimaryGS10
00841307129557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084130712955410841307129554
00841307129557008413071295578413071295570841307129557

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
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
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