FDA.reportPublic FDA data

AdDent

Primary DI
D8691120010
Brand
AdDent
Company
ADDENT, INC.
Model
OraBlu
Catalog number
112001
Device description
The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXVDiagnostic Light, Soft Tissue Detector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXVDiagnostic Light, Soft Tissue DetectorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121282000MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.2012-07-24NXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8691120010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Toluidine blue O solution IVDA toluidine blue O solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2037780200dpinto@addent.com

Regulatory Flags#

DUNS number
099490679
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8691300001AdDentCompex HD1300002026-04-22
D86911008001AdDentMicrolux 21100802017-06-01
D86962000706AdDentMicrolux6200072017-06-01
D8691100000AdDentCalset1100002017-06-01
D86911009002AdDentBio/Screen1100902017-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8136501180ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10030ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10050ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
D813PLS10080ViziLite®DEN-MAT HOLDINGS, LLCNXV2022-09-22
00860179001075FUSION-DOE Light SystemDentlight Inc.NXV2021-08-09
D86911009002AdDentADDENT, INC.NXV2017-06-01
07540201000094VELscopeLED Dental IncNXV2016-12-21
00754020100096VELscopeLED Dental IncNXV2016-12-21
D813PLS10010VIZILITE PRO DEN-MAT HOLDINGS, LLCNXV2016-11-14
08051040582003G.o.c.c.l.e.s.PIERREL SPANXV2016-10-21
08051040582010G.o.c.c.l.e.s. lightPIERREL SPANXV2016-10-21
00370275123163OralIDForward Science Technologies LLCNXV2016-10-03
07540201000032VELscopeLED Dental IncNXV2016-09-24
07540201000025VELscopeLED Dental IncNXV2016-09-24
27540201000036VELscopeLED Dental IncNXV2016-09-24
07540201000049VELscopeLED Dental IncNXV2016-09-24
00754020100041VELscopeLED Dental IncNXV2016-09-24
D8136501010 ViziLite®DEN-MAT HOLDINGS, LLCNXV2016-09-24
D702RT3003900StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-15
D702RT3001050StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003710StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003720StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003860StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
D702RT3003870StarDental Instrument SolutionsDENTALEZ, INC.NXV2016-09-13
07540201000018VELscopeLED Dental IncNXV2016-08-22
00754020100010VELscopeLED Dental IncNXV2016-08-22