| Primary Device ID | ECWGA351400U701 |
| NIH Device Record Key | 6b787183-863d-40f2-a78f-a55a2033fd20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Creation Willi Geller |
| Version Model Number | A351400U70 |
| Catalog Number | A351400U70 |
| Company DUNS | 301063590 |
| Company Name | KLEMA Dentalprodukte GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | ECWGA351400U701 [Primary] |
| ELM | Denture, Plastic, Teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-06 |
| ECWGC300300V651 | Creapearl C3 V65 |
| ECWGB200300V651 | Creapearl B2 V65 |
| ECWGA351400U701 | Creapearl A3,5 U7 |
| ECWGA351100U101 | Creapearl A3,5 U1 |
| ECWGA350800A751 | Creapearl A3,5 A75 |
| ECWGA350400V681 | Creapearl A3,5 V68 |
| ECWGA350300V651 | Creapearl A3,5 V65 |
| ECWGA301500U901 | Creapearl A3 U9 |
| ECWGA301200U301 | Creapearl A3 U3 |
| ECWGA301000A791 | Creapearl A3 A79 |
| ECWGA300900A781 | Creapearl A3 A78 |
| ECWGA300800A751 | Creapearl A3 A75 |
| ECWGA300700A731 | Creapearl A3 A73 |
| ECWGA300600A711 | Creapearl A3 A71 |
| ECWGA300500V691 | Creapearl A3 V69 |
| ECWGA201500U901 | Creapearl A2 U9 |
| ECWGA201000A791 | Creapearl A2 A79 |
| ECWGA200900A781 | Creapearl A2 A78 |
| ECWGA200800A751 | Creapearl A2 A75 |
| ECWGA200100V611 | Creapearl A2 V61 |
| ECWGA100900A781 | Creapearl A1 A78 |
| ECWG7005511 | CP/ Enamel Intensive SI-01+ |
| ECWG7005411 | CP/ Enamel Intensive SI-01 light yellow |
| ECWG7005271 | CP/ Enamel E57 |
| ECWG6521691 | ZI-F/ Approx. Dentine AD-2 orange |
| ECWG6521681 | ZI-F/ Approx. Dentine AD-1 light yellow |
| ECWG6521561 | ZI-F/ Neck Transpa HT-56 ochre |
| ECWG6521541 | ZI-F/ Neck Transpa HT-54 honey |
| ECWG6521531 | ZI-F/ Neck Transpa HT-53 sand |
| ECWG6521521 | ZI-F/ Neck Transpa HT-52 kaki |
| ECWG6521511 | ZI-F/ Neck Transpa HT-51 iridescent |
| ECWG6521441 | ZI-F/ Opaque Dentine OD-44 cuba |
| ECWG6521431 | ZI-F/ Opaque Dentine OD-43 ivory |
| ECWG6521411 | ZI-F/ Opaque Dentine OD-41 orange |
| ECWG6521371 | ZI-F/ Opaque Dentine OD-37 curry |
| ECWG6521321 | ZI-F/ Opaque Dentine OD-32 havanna |
| ECWG6520901 | ZI-F/ Correction Powder KM |
| ECWG6520861 | ZI-F/ Effect Enamel SO-11 orange |
| ECWG6520851 | ZI-F/ Effect Enamel SO-10 blue |
| ECWG6520831 | ZI-F/ Effect Enamel PS-3 orange |
| ECWG6520811 | ZI-F/ Effect Enamel PS-0 white |
| ECWG6520801 | ZI-F/ Transpa TI-5 grey |
| ECWG6520791 | ZI-F/ Transpa TI-4 yellow |
| ECWG6520781 | ZI-F/ Transpa TI-3 pink |
| ECWG6520771 | ZI-F/ Transpa TI-2 white |
| ECWG6520761 | ZI-F/ Transpa TI-1 blue |
| ECWG6520751 | ZI-F/ Transpa OT opal |
| ECWG6520741 | ZI-F/ Transpa NT neutral |
| ECWG6520731 | ZI-F/ Clear CL-O |
| ECWG6520701 | ZI-F/ Effect Enamel SI-06 heavy orange |