| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |