FDA.reportPublic FDA data

DLC Step Drill 4.4/3.8mm (6-16mmL)

Primary DI
10841307124795
Brand
DLC Step Drill 4.4/3.8mm (6-16mmL)
Company
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Model
SD4.4C
Catalog number
SD4.4C
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200265000Surgical DrillsImplant Direct Sybron Manufacturing, LLC2020-06-30DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841307124795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130712479510841307124795

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable 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
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10841307136033Legacy™ DIRECTarch™ 3.5mmD Platform Straight MUA 5.0mmL CollarDA8735-65S-AUDA8735-65S-AU2026-10-20
10841307136040Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 1.0mmL CollarDA8735-61-17S-AUDA8735-61-17S-AU2026-10-20
10841307136057Legacy™ DIRECTarch™ 3.5mmD Platform 17° MUA 2.0mmL CollarDA8735-62-17S-AUDA8735-62-17S-AU2026-10-20
10841307136064Legacy™ DIRECTarch™ 3.5mmD Platform 30° MUA 1.0mmL CollarDA8735-61-30S-AUDA8735-61-30S-AU2026-10-20
10841307136071Legacy™ DIRECTarch™ 3.5mmD Platform 30° MUA 2.0mmL CollarDA8735-62-30S-AUDA8735-62-30S-AU2026-10-20

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