FDA.reportPublic FDA data

Ceramir Pediatric Crown 61/F Size L

Primary DI
09120046325927
Brand
Ceramir Pediatric Crown 61/F Size L
Company
edelweiss dentistry products gmbh
Model
805122
Device description
1x Ceramir Pediatric Crown 61/F Size Large
Published
2024-03-06
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
ELZCrown, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120046325927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120046325927091200463259279120046325927

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300537672
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
09120046322414edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18)191002024-11-04
09120046322421edelweiss CAD/CAM C-BLOCK A0 (12/14/18)191012024-11-04
09120046322438edelweiss CAD/CAM C-BLOCK A1 (12/14/18)191022024-11-04
09120046322445edelweiss CAD/CAM C-BLOCK A2 (12/14/18)191032024-11-04
09120046322452edelweiss CAD/CAM C-BLOCK A3 (12/14/18)191042024-11-04
09120046322476edelweiss CAD/CAM i-BLOCK (ØS) Universal Enamel19100.A2024-11-04
09120046322483edelweiss CAD/CAM i-BLOCK (ØS) A019101.A2024-11-04
09120046322490edelweiss CAD/CAM i-BLOCK (ØS) A119102.A2024-11-04
09120046322506edelweiss CAD/CAM i-BLOCK (ØS) A219103.A2024-11-04
09120046322513edelweiss CAD/CAM i-BLOCK (ØS) A319104.A2024-11-04
09120046322537edelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16)211002024-11-04
09120046322544edelweiss CAD/CAM C-BLOCK A0 (10/12/16)211012024-11-04
09120046322551edelweiss CAD/CAM C-BLOCK A1 (10/12/16)211022024-11-04
09120046322568edelweiss CAD/CAM C-BLOCK A2 (10/12/16)211032024-11-04
09120046322575edelweiss CAD/CAM C-BLOCK A3 (10/12/16)211042024-11-04
09120046325132edelweiss CAD/CAM i-BLOCK (ØL) Universal Enamel19100.A.L2024-11-04
09120046325149edelweiss CAD/CAM i-BLOCK (ØL) A019101.A.L2024-11-04
09120046325156edelweiss CAD/CAM i-BLOCK (ØL) A119102.A.L2024-11-04
09120046325163edelweiss CAD/CAM i-BLOCK (ØL) A219103.A.L2024-11-04
09120046325170edelweiss CAD/CAM i-BLOCK (ØL) A319104.A.L2024-11-04

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