FDA.reportPublic FDA data

Dental Basics

Primary DI
00850061028006
Brand
Dental Basics
Company
Dental Basics Inc.
Model
BE21
Device description
Phosphor Plate Barrier Envelopes, Size 1, Top Opening
Published
2024-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163447000Premium Plus Disposable Barrier SleevePremium Plus International Limited2017-06-20PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061028006PrimaryGS10
20850061028000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061028006008500610280068500610280060850061028006
2085006102800020850061028000

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassetteA device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.

Regulatory Flags#

DUNS number
119194176
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850061028024Dental BasicsBE102024-05-08
00850061028013Dental BasicsBE222024-05-08
00850061028037Dental BasicsBE112024-05-08
00850061028044Dental BasicsBE122024-05-08
00850061028051Dental BasicsBE202024-05-08
00850061028068Dental BasicsMA102024-05-08
00850061028075Dental BasicsMA112024-05-08
00850061028082Dental BasicsMA122024-05-08
00850061028099Dental BasicsMA132024-05-08
00850061028105Dental BasicsMA202024-05-08
00850061028112Dental BasicsMA212024-05-08
00850061028129Dental BasicsMA222024-05-08
00850061028136Dental BasicsAW102024-05-08
00850061028167Dental BasicsPA112024-05-08
00850061028174Dental BasicsPA122024-05-08
00850061028181Dental BasicsPA132024-05-08
00850061028198Dental BasicsPA142024-05-08
00850061028204Dental BasicsPA152024-05-08
00850061028020Dental BasicsBE102024-05-08
20850061028000Dental BasicsBE212024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06
00840456220740JMUJMU DENTAL, INCPEM2026-07-06
00840456220757JMUJMU DENTAL, INCPEM2026-07-06
00840456220764JMUJMU DENTAL, INCPEM2026-07-06
00840456220771JMUJMU DENTAL, INCPEM2026-07-06
00840456220788JMUJMU DENTAL, INCPEM2026-07-06
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187140VALOTIDI PRODUCTS, LLCPEM2025-08-29