FDA.reportPublic FDA data

EZCrown

Primary DI
00819235020161
Brand
EZCrown
Company
Sprig Oral Health Technologies, Inc.
Model
R-EZC-MAX-PK
Device description
Posterior Maxillary Pro Kit - 144 Crowns
Published
2022-12-05
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
00819235020161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819235020161008192350201618192350201610819235020161

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
Kit
true
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
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
00819235020284EZCrownR-EZC-P-A6SL2022-12-01

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