FDA.reportPublic FDA data

Step Drill 2.3/2.0

Primary DI
00810157313898
Brand
Step Drill 2.3/2.0
Company
Paragon Implant Mfg., LLC
Model
SD2.3
Catalog number
SD2.3
Device description
Step Drill 2.3/2.0, 7-14mmL, Long
Published
2026-01-07
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRQNon-Irrigation Endosseous Dental Implant Drill Bits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRQNon-Irrigation Endosseous Dental Implant Drill BitsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810157313898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810157313898008101573138988101573138980810157313898

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-855-649-4365info@paragon-implant.com

Regulatory Flags#

DUNS number
118698566
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00810157313331NizPlant Insertion ToolNPIT-LNPIT-L2026-02-13
00810157313775NizPlant Insertion ToolNPIT-SNPIT-S2026-02-13
00810157311566NizPlant TransferNPT-NRNPT-NR2026-01-30
00810157313706NizPlant Imp. Center ScrewNPCSNPCS2026-01-30
00810157313751NizPlant Fixation Screw NPFSXSNPFSXS2026-01-30
00810157314130Ext. NizLoc Abutment ScrewXTNL-0XTNL-02026-01-30
00810157314147Ext. NizLoc Abutment ScrewXTNL-1XTNL-12026-01-30
00810157314154Ext. NizLoc Abutment ScrewXTNL-2XTNL-22026-01-30
00810157313133NizLoc AbutmentNL35-11NL35-112026-01-29
00810157313140NizLoc AbutmentNL35-12NL35-122026-01-29
00810157313157NizLoc AbutmentNL35-13NL35-132026-01-29
00810157313164NizLoc AbutmentNL35-14NL35-142026-01-29
00810157313171NizLoc AbutmentNL35-15NL35-152026-01-29
00810157313188NizLoc AbutmentNL45-11NL45-112026-01-29
00810157313195NizLoc AbutmentNL45-12NL45-122026-01-29
00810157313201NizLoc AbutmentNL45-13NL45-132026-01-29
00810157313218NizLoc AbutmentNL45-14NL45-142026-01-29
00810157313225NizLoc AbutmentNL45-15NL45-152026-01-29
00810157311467Extender MUA Screw (4 pcs)XTMAW-60-4XTMAW-60-42026-01-09
00810157310071Closed-Tray Implant TransferCT35-ENCT35-EN2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810157313881Starter DrillParagon Implant Mfg., LLCQRQ2026-01-07
00810157313904Step Drill 2.8/2.3Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313911Step Drill 3.4/2.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313928Step Drill 3.8/3.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313935Step Drill 4.4/3.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313942Step Drill 4.8/4.4Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313959Step Drill 5.1/4.8Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313966Step Drill 5.4/5.1Paragon Implant Mfg., LLCQRQ2026-01-07
00810157313027Lindemann DrillParagon Implant Mfg., LLCQRQ2025-12-30
00810157312952Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312969Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-29
00810157312938Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312945Ruby Hex DrillParagon Implant Mfg., LLCQRQ2025-12-24
00810157312631Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-18
00810157310101Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312594Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312600Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312617Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
00810157312624Crestal DrillParagon Implant Mfg., LLCQRQ2025-12-17
07290119310449Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310456Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310463Pterygoid Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310470Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310487Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310494Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310500Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310517Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310524Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310531Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18
07290119310548Zygomatic Implant DrillBIOLINE DENTAL IMPLANT SYSTEMS LTDQRQ2025-03-18