FDA.reportPublic FDA data

Precision Dental Instruments

Primary DI
00850000052741
Brand
Precision Dental Instruments
Company
Precision Dental Instruments
Model
PI-9-138
Published
2019-01-27
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
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000052741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000052741008500000527418500000527410850000052741

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081290121
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000052567Precision Dental Instruments PI-9-1222019-01-27
00850000052901Precision Dental Instruments PI-9-1522019-01-27
00850000052925Precision Dental Instruments PI-9-1562019-01-27
00850000052949Precision Dental Instruments PI-9-1582019-01-27
00850000052017Precision Dental Instruments PDIPI-9-3PI-9-32019-01-27
00850000052024Precision Dental Instruments - PDIPI-9-52019-01-27
00850000052031Precision Dental Instruments PI-9-102019-01-27
00850000052048Precision Dental Instruments PI-9-11PI-9-112019-01-27
00850000052055Precision Dental Instruments PI-9-12PI-9-122019-01-27
00850000052062Precision Dental Instruments PI-9-132019-01-27
00850000052079Precision Dental Instruments PI-9-152019-01-27
00850000052086Precision Dental Instruments PI-9-19PI-9-192019-01-27
00850000052093Precision Dental Instruments PI-9-202019-01-27
00850000052109Precision Dental Instruments PI-9-62019-01-27
00850000052123Precision Dental Instruments PI-9-222019-01-27
00850000052130Precision Dental Instruments PI-9-23PI-9-232019-01-27
00850000052161Precision Dental Instruments PI-9-27PI-9-272019-01-27
00850000052178Precision Dental Instruments PI-9-292019-01-27
00850000052185Precision Dental Instruments PI-9-30PI-9-302019-01-27
00850000052208Precision Dental Instruments PI-9-342019-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G8791021190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021196L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102131H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102132H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102133H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102134H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102135H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102136H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
00887919683902Brasseler USAPeter Brasseler Holdings, LLCEKB2026-07-13
08800017902470FriendoDXM CO., LTDEKB2026-07-13
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08800017902494Gutta EasyDXM CO., LTDEKB2026-07-13
00850083275686Intrace USAPILOTIS TECH LLCEKB2026-07-03
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010027HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12