FDA.reportPublic FDA data

Premier Probes

Primary DI
00348783006391
Brand
Premier Probes
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1003640
Device description
Probes SE_UNC 15
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIXProbe, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783006391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783006391003487830063913487830063910348783006391

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021511B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102151H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102157H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102158H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102159H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910217U150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223C1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223GF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791022NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791023AU150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791026QW0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP02H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102GFP0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102W11B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102WGF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
B382SD19300Surgical DirectSurgical Direct, Inc.EIX2026-07-31
08057639712677Needle tip - BLKMC BIO SRLEIX2026-07-28
08057639712684Needle tipMC BIO SRLEIX2026-07-28
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08