FDA.reportPublic FDA data

Intrace USA

Primary DI
00850090726287
Brand
Intrace USA
Company
PILOTIS TECH LLC
Model
INT-DNT-DPR-034-001
Catalog number
INT-DNT-DPR-034-001
Device description
Burnisher, Fig. 26/27S, Double-Ended, Stainless Steel, Reusable.
Published
2026-10-31
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850090726287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850090726287008500907262878500907262870850090726287

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
4049196896info@intrace.us

Regulatory Flags#

DUNS number
110680677
Device count
1
DM exempt
false
Premarket exempt
true
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
00850090726003Intrace USAINT-SRG-ENT-145-002INT-SRG-ENT-145-0022026-10-31
00850090726010Intrace USAINT-SRG-ENT-145-001INT-SRG-ENT-145-0012026-10-31
00850090726027Intrace USAINT-SRG-ENT-145-003INT-SRG-ENT-145-0032026-10-31
00850090726034Intrace USAINT-DNT-EXT-004-004INT-DNT-EXT-004-0042026-10-31
00850090726041Intrace USAINT-DNT-EXT-004-003INT-DNT-EXT-004-0032026-10-31
00850090726058Intrace USAINT-DNT-DPR-106-002INT-DNT-DPR-106-0022026-10-31
00850090726065Intrace USAINT-DNT-DPR-106-001INT-DNT-DPR-106-0012026-10-31
00850090726072Intrace USAINT-SRG-GYN-206-003INT-SRG-GYN-206-0032026-10-31
00850090726089Intrace USAINT-DNT-EXT-009-003INT-DNT-EXT-009-0032026-10-31
00850090726096Intrace USAINT-DNT-MXF-097INT-DNT-MXF-0972026-10-31
00850090726102Intrace USAINT-DNT-DPR-160-002INT-DNT-DPR-160-0022026-10-31
00850090726119Intrace USAINT-DNT-DPR-160-001INT-DNT-DPR-160-0012026-10-31
00850090726126Intrace USAINT-DNT-MXF-163-002INT-DNT-MXF-163-0022026-10-31
00850090726133Intrace USAINT-DNT-DPR-207INT-DNT-DPR-2072026-10-31
00850090726140Intrace USAINT-DNT-DPR-206INT-DNT-DPR-2062026-10-31
00850090726157Intrace USAINT-DNT-MXF-029-002INT-DNT-MXF-029-0022026-10-31
00850090726164Intrace USAINT-SRG-OPH-062-003INT-SRG-OPH-062-0032026-10-31
00850090726171Intrace USAINT-SRG-OPH-062-004INT-SRG-OPH-062-0042026-10-31
00850090726188Intrace USAINT-SRG-OPH-062-005INT-SRG-OPH-062-0052026-10-31
00850090726195Intrace USAINT-SRG-OPH-062-006INT-SRG-OPH-062-0062026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD23170Surgical DirectSurgical Direct, Inc.EKJ2026-10-15
B382SD25090Surgical DirectSurgical Direct, Inc.EKJ2026-10-15
B382SD28020Surgical DirectSurgical Direct, Inc.EKJ2026-07-31
00850083275655Intrace USAPILOTIS TECH LLCEKJ2026-07-03
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
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