FDA.reportPublic FDA data

White Bite

Primary DI
00850056330152
Brand
White Bite
Company
White Bite, Inc.
Model
U2
Catalog number
U2
Device description
Pediatric Strip Crown Form Upper Cuspid 2
Published
2025-10-27
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
KCQTube Impression And Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCQTube Impression And MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056330152PrimaryGS10
10850056330159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056330152008500563301528500563301520850056330152
1085005633015910850056330159

GMDN Terms#

Term, Definition table
TermDefinition
Dental mouldA hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.

Regulatory Flags#

DUNS number
174136221
Device count
5
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056330008White BiteE5E52025-10-27
00850056330015White BiteE6E62025-10-27
00850056330022White BiteF1F12025-10-27
00850056330039White BiteF2F22025-10-27
00850056330046White BiteF3F32025-10-27
00850056330053White BiteF4F42025-10-27
00850056330060White BiteF5F52025-10-27
00850056330077White BiteF6F62025-10-27
00850056330084White BiteG1G12025-10-27
00850056330091White BiteG2G22025-10-27
00850056330107White BiteG3G32025-10-27
00850056330114White BiteG4G42025-10-27
00850056330121White BiteG5G52025-10-27
00850056330138White BiteG6G62025-10-27
00850056330145White BiteU1U12025-10-27
00850056330169White BiteU3U32025-10-27
00850056330176White BiteU4U42025-10-27
00850056330183White BiteU5U52025-10-27
00850056330206White BiteL1L12025-10-27
00850056330220White BiteL3L32025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008101265033053D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
008101265062143D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKCQ2025-12-16
00850056330008White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330015White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330022White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330039White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330046White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330053White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330060White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330077White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330084White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330091White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330107White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330114White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330121White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330138White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330145White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330169White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330176White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330183White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330206White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330220White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330237White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330244White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330251White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330541White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330558White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330565White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330572White BiteWhite Bite, Inc.KCQ2025-10-27
00850056330589White BiteWhite Bite, Inc.KCQ2025-10-27