FDA.reportPublic FDA data

Bioflx Crown

Primary DI
08906154843376
Brand
Bioflx Crown
Company
KIDS-E-DENTAL LLP
Model
BFX-CLPK
Device description
Central & Lateral Incisor Professional Kit "Kit - 32 Crowns Central Incisor 2,3,4- 4 units each Lateral Incisor 2,3,4- 4 units each Central Incisor 1,5- 2 units each Lateral Incisor 1,5 - 2 units each"
Published
2026-05-30
Public version status
New
Distribution status
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
ELZCrown, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906154843376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906154843376089061548433768906154843376

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
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
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
08906154843444Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843451Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30
08906154843468Bioflx CrownKIDS-E-DENTAL LLPELZ2026-05-30