FDA.reportPublic FDA data

Fixation Screw

Primary DI
00841307132311
Brand
Fixation Screw
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
1000-27
Catalog number
1000-27
Published
2025-01-31
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
K081101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081101000SPECTRA-SYSTEM ABUTMENTS 2008Implant Direct, LLC2009-01-14NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307132318PrimaryGS10
00841307132311Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084130713231810841307132318
00841307132311008413071323118413071323110841307132311

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

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
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
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
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088000968582178plant Implant System8dent Inc.NHA2026-10-23
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088000968582318plant Implant System8dent Inc.NHA2026-10-23
088000968585528plant Implant System8dent Inc.NHA2026-10-23
088000968587058plant Implant System8dent Inc.NHA2026-10-23
088000968599008plant Implant System8dent Inc.NHA2026-10-23
088000968600298plant Implant System8dent Inc.NHA2026-10-23
088000968600508plant Implant System8dent Inc.NHA2026-10-23
088000968601808plant Implant System8dent Inc.NHA2026-10-23
088000968602038plant Implant System8dent Inc.NHA2026-10-23
088000968608768plant Implant System8dent Inc.NHA2026-10-23
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088000968617368plant Implant System8dent Inc.NHA2026-10-23
088000968617438plant Implant System8dent Inc.NHA2026-10-23
088000968618288plant Implant System8dent Inc.NHA2026-10-23
088000968618358plant Implant System8dent Inc.NHA2026-10-23
088000968620098plant Implant System8dent Inc.NHA2026-10-23
088000968620168plant Implant System8dent Inc.NHA2026-10-23
088000968620238plant Implant System8dent Inc.NHA2026-10-23
088000968622698plant Implant System8dent Inc.NHA2026-10-23
088000968622768plant Implant System8dent Inc.NHA2026-10-23
088000968650248plant Implant System8dent Inc.NHA2026-10-23
088000968650798plant Implant System8dent Inc.NHA2026-10-23
088000968688418plant Implant System8dent Inc.NHA2026-10-23
088000968688588plant Implant System8dent Inc.NHA2026-10-23