FDA.reportPublic FDA data

edelweiss Pediatric Crown 65/J Size M

Primary DI
09120046323763
Brand
edelweiss Pediatric Crown 65/J Size M
Company
edelweiss dentistry products gmbh
Model
17230
Device description
2x edelweiss Pediatric Crown 65/J Size Medium
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
09120046323763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120046323763091200463237639120046323763

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810118106644NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106651NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106682NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106842NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106859NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106866NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106873NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106880NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106897NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106903NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106910NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106927NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106934NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106941NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106958NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106965NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106972NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106989NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118106996NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107009NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107016NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107023NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107030NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107047NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107054NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107061NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107078NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107085NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107092NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26
00810118107108NuSmile ReVIVE CrownsNUSMILE, LTD.ELZ2025-11-26