FDA.reportPublic FDA data

White Bite

Primary DI
00850075846122
Brand
White Bite
Company
White Bite, Inc.
Model
ASCUR6
Catalog number
ASCUR6
Device description
Adult Strip Crown Form Cuspid Upper Right 6
Published
2026-05-27
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00850075846122PrimaryGS10
10850075846129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075846122008500758461228500758461220850075846122
1085007584612910850075846129

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
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075846108White BiteASCUL6ASCUL62026-05-27
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
00850056330152White BiteU2U22025-10-27
00850056330169White BiteU3U32025-10-27
00850056330176White BiteU4U42025-10-27
00850056330183White BiteU5U52025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075846108White BiteWhite Bite, Inc.KCQ2026-05-27
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
00850056330152White 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