EZCrown

Primary DI
00819235021144
Brand
EZCrown
Company
Sprig Oral Health Technologies, Inc.
Model
R-EZC-P-T7
Device description
Sprig Posterior Crown -Mandibular Right Second Molar
Published
2022-12-01
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091362000CERAMIC PEDATRIC PREFORMED CROWNEz-Pedo, Inc.2009-06-29ELZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819235021144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819235021144008192350211448192350211440819235021144

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

Regulatory Flags#

DUNS number
029458526
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819235022189SmartMTA Capsule R-MTA-C102023-05-18
00819235022196SmartMTA CapsuleR-MTA-C202023-05-18
00819235020093EZCrownR-EZC-A-PK2022-12-05
00819235020109EZCrownR-EZC-A-SK2022-12-05
00819235020116EZCrownR-EZC-MAN-MK2022-12-05
00819235020123EZCrownR-EZC-MAN-PK2022-12-05
00819235020130EZCrownR-EZC-MAN-SK2022-12-05
00819235020147EZCrownR-EZC-MAX-SK2022-12-05
00819235020154EZCrownR-EZC-MAX-MK2022-12-05
00819235020161EZCrown R-EZC-MAX-PK2022-12-05
00819235020086EZCrownR-EZC-A-MK2022-12-01
00819235020192EZCrownR-EZC-P-A22022-12-01
00819235020208EZCrownR-EZC-P-A2SL2022-12-01
00819235020215EZCrownR-EZC-P-A32022-12-01
00819235020222EZCrownR-EZC-P-A3SL2022-12-01
00819235020239EZCrownR-EZC-P-A42022-12-01
00819235020246EZCrownR-EZC-P-A4SL2022-12-01
00819235020253EZCrownR-EZC-P-A52022-12-01
00819235020260EZCrownR-EZC-P-A5SL2022-12-01
00819235020277EZCrownR-EZC-P-A62022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040188832Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
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10304040188894Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040188924Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040188931Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040188979Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040188993Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189013Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189051Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189099Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189105Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189204Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189242Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189266Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189280Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189327Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189334Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189389Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189433Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189464Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189488Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189525Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189532Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040189549Henry ScheinHENRY SCHEIN, INC.ELZ2024-12-31
10304040054359Henry ScheinHENRY SCHEIN, INC.ELZ2020-08-24
10304040054373Henry ScheinHENRY SCHEIN, INC.ELZ2020-08-24
10304040054380Henry ScheinHENRY SCHEIN, INC.ELZ2020-08-24
10304040054397Henry ScheinHENRY SCHEIN, INC.ELZ2020-08-24
10304040054403Henry ScheinHENRY SCHEIN, INC.ELZ2020-08-24