FDA.reportPublic FDA data

Kids-e-crown

Primary DI
08906154840498
Brand
Kids-e-crown
Company
KIDS-E-DENTAL LLP
Model
KEC-DLR5
Device description
Pediatric- preformed zirconia crown Posterior First Molar - Lower Right size S5 (DLR5)
Published
2024-03-20
Public version status
Update
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
ELZCrown, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906154840498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906154840498089061548404988906154840498

GMDN Terms#

Term, Definition table
TermDefinition
Preformed dental crown, temporaryA prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
861296265
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906154842393Bioflx CrownBFX-AMK2026-05-30
08906154842409Bioflx CrownBFX-CLMK2026-05-30
08906154842416Bioflx CrownBFX-CSK2026-05-30
08906154842423Bioflx CrownBFX-CMK2026-05-30
08906154842430Bioflx CrownBFX-CLSK2026-05-30
08906154842447Bioflx CrownBFX-A12026-05-30
08906154842454Bioflx CrownBFX-A22026-05-30
08906154842461Bioflx CrownBFX-A32026-05-30
08906154842478Bioflx CrownBFX-A42026-05-30
08906154842485Bioflx CrownBFX-A52026-05-30
08906154842492Bioflx CrownBFX-B12026-05-30
08906154842508Bioflx CrownBFX-B22026-05-30
08906154842515Bioflx CrownBFX-B32026-05-30
08906154842522Bioflx CrownBFX-B42026-05-30
08906154842539Bioflx CrownBFX-B52026-05-30
08906154842546Bioflx CrownBFX-LC12026-05-30
08906154842553Bioflx CrownBFX-LC22026-05-30
08906154842560Bioflx CrownBFX-LC32026-05-30
08906154842577Bioflx CrownBFX-LC42026-05-30
08906154842584Bioflx CrownBFX-LC52026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906154842393Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842409Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842416Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842423Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842430Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842447Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842454Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842461Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842478Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842485Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842492Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842508Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842515Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842522Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842539Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842546Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842553Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842560Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842577Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842584Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842591Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842607Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842614Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842621Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154842638Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843352Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843369Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843376Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843444Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843451Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30