FDA.reportPublic FDA data

Chang's Iris

Primary DI
08800118607229
Brand
Chang's Iris
Company
U&C International Co.,Ltd
Model
Iris F1 22T
Published
2022-02-12
Public version status
New
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191902000Razor, Everest, U&C LiquidU&C International Co., Ltd.2019-10-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800118607229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800118607229088001186072298800118607229

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694821663
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800118646365ZublerW 1100 XA1 222026-01-05
08800118646372ZublerW 1100 XA1 202026-01-05
08800118646389Razor / MegaPlusW 1100 BL3 352026-01-05
08800118646396Razor / MegaPlusW 1100 BL2 352026-01-05
08800118646402Razor / MegaPlusW 1100 BL1 352026-01-05
08800118646419ZublerW 1100 ABL3 352026-01-05
08800118646426ZublerW 1100 ABL3 222026-01-05
08800118646433ZublerW 1100 ABL3 202026-01-05
08800118646440ZublerW 1100 AB1 222026-01-05
08800118646457ZublerW 1100 AB1 202026-01-05
08800118646464Razor / MegaPlusW 1100 A2 352026-01-05
08800118623984Razor / MegaPlusW 1300 A3.5 102023-03-03
08800118623991Razor / MegaPlusW 1300 A3.5 122023-03-03
08800118624004Razor / MegaPlusW 1300 A3.5 142023-03-03
08800118624011Razor / MegaPlusW 1300 A3.5 162023-03-03
08800118624028Razor / MegaPlusW 1300 A3.5 182023-03-03
08800118624035Razor / MegaPlusW 1300 A3.5 202023-03-03
08800118624042Razor / MegaPlusW 1300 A3.5 222023-03-03
08800118624059Razor / MegaPlusW 1300 A3.5 252023-03-03
08800118624066Razor / MegaPlusW 1300 A3.5 282023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36030Colour Liquid Prettau B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA37020Colour Liquid Prettau B2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28