| Primary Device ID | D745701026CAP00091 |
| NIH Device Record Key | 36727cd3-14fb-416e-b689-d814a5e3bb8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Metal Quadrant Impression Trays |
| Version Model Number | 70-1026-CAP0009 |
| Catalog Number | 70-1026-CAP0009 |
| Company DUNS | 021228671 |
| Company Name | James R. Glidewell, Dental Ceramics, Inc. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D745701026CAP00090 [Primary] |
| HIBCC | D745701026CAP00091 [Unit of Use] |
| EHY | TRAY, IMPRESSION, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-13 |
| Device Publish Date | 2023-07-05 |
| D745701026CAP00101 | Metal Quadrant Impression Trays, 250-pack |
| D745701026CAP00091 | Metal Quadrant Impression Trays, 50-pack |