FDA.reportPublic FDA data

HurriView II

Primary DI
00723797110515
Brand
HurriView II
Company
BEUTLICH PHARMACEUTICALS, LLC
Model
base unit
Device description
Two-Tone Dental Plaque Disclosing Liquid; swab, each
Published
2019-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJCPlaque Disclosing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJCPlaque Disclosing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01723797110576PackageGS172Not in Commercial Distribution
02723797110575PackageGS124Not in Commercial Distribution
00723797110515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01723797110576017237971105761723797110576
02723797110575027237971105752723797110575
00723797110515007237971105157237971105150723797110515

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detecting stainA liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
8002388542Regulatory@Beutlich.com

Regulatory Flags#

DUNS number
005209325
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10723797170615InstaNumb17060283-1706-442026-04-15
10723797170721InstaNumb17070283-1707-442026-04-15
10723797170837InstaNumb17080283-1708-442026-04-15
10723797170943InstaNumb17090283-1709-442026-04-15
10723797806446Hurri-Freeze115mL Mist2025-12-15
10723797807443Hurri-Freeze115mL Medium Stream2025-12-15
10723797809447Hurri-Freeze35mL Mist2025-12-15
20723797806443Hurri-Freeze115mL Mist2025-12-15
20723797807440Hurri-Freeze115mL Medium Stream2025-12-15
10723797808440Hurri-Freeze35mL Medium Stream0283-1808-442025-12-15
20723797809444Hurri-Freeze35mL Mist2025-12-15
00723797697115HurriSeal Dentin Desensitizer Snap-N-Go SwabSnap-N-Go Swab2016-10-01
10723797697143HurriSeal Dentin Desensitizer 5mL5mL bottle2020-01-07
10723797697822HurriSeal Dentin Desensitizer 12mL12mL bottle2020-01-07
01723797697145HurriSeal Dentin Desensitizer 5mL5mL bottle2016-10-01
01723797697824HurriSeal Dentin Desensitizer 12mL12mL bottle2016-10-01
00723797010419HurriViewbase unit2019-10-01
02723797104727HurriViewbase unit2019-10-01
02723797110575HurriView IIbase unit2019-10-01
02723797697113HurriSeal Dentin Desensitizer Snap-N-Go SwabSnap-N-Go Swab2016-10-01

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Primary DI, Brand, Company table
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D2486057681Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-08
00302732311028Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322000Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322109Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322253Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
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00302732342008Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
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