FDA.reportPublic FDA data

iLumi

Primary DI
00850692005230
Brand
iLumi
Company
Ilumi Sciences, Inc.
Model
XK-60123
Device description
20 XW Fiber Posts, 5 each 1.10,1.35,1.47, 1.67mm & 4 matching drills. (Asst. Kit)
Published
2024-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850692005230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850692005230008506920052308506920052300850692005230

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. 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

Regulatory Flags#

DUNS number
058316335
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850692005179iLumiSK-801232024-03-06
00850692005063iLumiDR-01352022-05-23
00850692005070iLumiDR-01472022-05-23
00850692005087iLumiDR-01672022-05-23
00850692005247iLumiXR-61352022-05-23
00850692005254iLumiXR-61472022-05-23
00850692005261iLumiXR-61672022-05-23
00850692005308iLumiXR-61102022-05-23
00850692005339iLumiDR-01102022-05-23
00850692005445iLumiXK-61232022-05-23
00850692005612iLumiSD-81472022-05-23
00850692005629iLumiSD-81672022-05-23
00850692005650iLumiSD-91472022-05-23
00850692005698iLumiSK-91232022-05-23
00850692005704iLumiSR-91352022-05-23
00850692005711iLumiSR-91472022-05-23
00850692005728iLumiSR-91672022-05-23
00850692005759iLumiXD-61102022-05-23
00850692005766iLumiSD-91352022-05-23
00850692005773iLumiXD-61472022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116660677Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-07-12
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195393992DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395033DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395040DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395057DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395064DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395088DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395101DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395118DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10