FDA.reportPublic FDA data

Precision Dental Instruments

Primary DI
00850000052567
Brand
Precision Dental Instruments
Company
Precision Dental Instruments
Model
PI-9-122
Published
2019-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000052567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000052567008500000525678500000525670850000052567

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance dimension gaugeA dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). 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
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
00850000052215Precision Dental Instruments PI-9-352019-01-27

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Primary DI, Brand, Company table
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00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05