DURALAY - CLEAR
- Primary DI
- D9472249DC1
- Brand
- DURALAY - CLEAR
- Company
- Reliance Dental Manufacturing Co Inc
- Model
- 2249D-C
- Device description
- INLAY PATTERN RESIN/1 OZ. POWDER / 1 OZ. LIQUID (28 GR POWDER / 30 ML LIQUID)
- Published
- 2022-08-03
- 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
- false
Product Codes
| Code | Name |
|---|
| EBH | Material, Impression Tray, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBH | Material, Impression Tray, Resin | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D9472249DC1 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental impression tray material | A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device. |
Regulatory Flags
- DUNS number
- 005139159
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- 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 | Catalog | Published |
|---|
| D9471701 | Dura Rely-A-Soft Complete Package - Pink | 1701 | | 2022-08-23 |
| D9471701C1 | Dura Rely-A-Soft Complete Package - Clear | 1701-C | | 2022-08-23 |
| D9471706 | Dura Rely-A-Soft Economy Package - Pink | 1706 | | 2022-08-23 |
| D9471706C1 | Dura Rely-A-Soft Economy Package - Clear | 1706-C | | 2022-08-23 |
| D9471801 | Dura Conditioner Complete Package - White | 1801 | | 2022-08-23 |
| D9471801P1 | Dura Conditioner Complete Package - Pink | 1801-P | | 2022-08-23 |
| D9471805 | Dura Conditioner Bulk Package - White | 1805 | | 2022-08-23 |
| D9471805P1 | Dura Conditioner Bulk Package - Pink | 1805-P | | 2022-08-23 |
| D9471401C1 | Durabase - Clear | 1401-C | | 2022-08-03 |
| D9471506C1 | Durabase Soft - Clear | 1506-C | | 2022-08-03 |
| D9471601C1 | Duraliner II - Clear | 1601-C | | 2022-08-03 |
| D9471601N1 | Duraliner II – Nylon Fiber | 1601-N | | 2022-08-03 |
| D9472243B1 | DURALAY - BLUE | 2243-B | | 2022-08-03 |
| D9472243C1 | DURALAY - CLEAR | 2243-C | | 2022-08-03 |
| D9472244 | DURALAY - Red | 2244 | | 2022-08-03 |
| D9472244B1 | DURALAY - BLUE | 2244-B | | 2022-08-03 |
| D9472244C1 | DURALAY - CLEAR | 2244-C | | 2022-08-03 |
| D9472249A1 | DURALAY - Red | 2249A | | 2022-08-03 |
| D9472249AB1 | DURALAY - BLUE | 2249A-B | | 2022-08-03 |
| D9472249AC1 | DURALAY - CLEAR | 2249A-C | | 2022-08-03 |
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|---|
| 08906139320670 | Taglus Model Resin | LAXMI DENTAL LIMITED | EBH | 2026-01-09 |
| 08906139320694 | Taglus Model Resin S | LAXMI DENTAL LIMITED | EBH | 2026-01-09 |
| 08906139323473 | Taglus Model Resin Odourless | LAXMI DENTAL LIMITED | EBH | 2026-01-09 |
| 06975338701292 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBH | 2025-12-09 |
| 06975338701308 | SHINING 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | EBH | 2025-12-09 |
| 00850061175151 | H-0600 Resin | FORMLABS OHIO INC. | EBH | 2025-12-01 |
| EDET047221 | RS VIVO IBT 1000g | DETAX GmbH | EBH | 2025-11-20 |
| E235S3DMR0 | Dentaprint | SHOFU DENTAL CORPORATION | EBH | 2025-08-26 |
| E235S3DOR0 | Dentaprint | SHOFU DENTAL CORPORATION | EBH | 2025-08-26 |
| 07701126901075 | Portux 3D Printing Resin Basic Gray x 500g | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | EBH | 2025-08-11 |
| 07701126901204 | Portux 3D Printing Resin Dental Models | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | EBH | 2025-08-11 |
| 07701126901235 | Portux 3D Printing Resin Model 2.0 | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A | EBH | 2025-08-11 |
| 04260635981587 | RS VIVO Tray | DeltaMed GmbH | EBH | 2025-07-29 |
| EDEL16216200 | 3Delta Tray Rose | DeltaMed GmbH | EBH | 2025-07-29 |
| D7091084045 | M-PRINT TryIn | Merz Dental GmbH | EBH | 2025-07-08 |
| D7091084046 | M-PRINT TryIn | Merz Dental GmbH | EBH | 2025-07-08 |
| D7091084047 | M-PRINT TryIn | Merz Dental GmbH | EBH | 2025-07-08 |
| D7091084048 | M-PRINT TryIn | Merz Dental GmbH | EBH | 2025-07-08 |
| 16978499313042 | RAYFORM Technology | Ziyang Rayform Technology Co., Ltd. | EBH | 2025-05-09 |
| EPRC768507 | UCAN Print Tray | pro3dure medical GmbH | EBH | 2025-03-31 |
| E239D4210ZS1 | Drufoplast | Dreve Dentamid GmbH | EBH | 2025-03-21 |
| 06975471800036 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800043 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800050 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800067 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800074 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800081 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800098 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800104 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
| 06975471800111 | Pionext | Shenzhen Piocreat 3D Technology Co., Ltd | EBH | 2024-12-26 |
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