| Primary Device ID | 10889813067670 | 
| NIH Device Record Key | 28eceece-61a3-4a2c-abcc-9f8741b67800 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Darby Dental Supply, LLC | 
| Version Model Number | 9553134 | 
| Company DUNS | 825137818 | 
| Company Name | DARBY DENTAL SUPPLY, LLC | 
| Device Count | 72 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00889813067673 [Primary] | 
| GS1 | 10889813067670 [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 | 2025-07-10 | 
| Device Publish Date | 2025-07-02 | 
| D82795320301 | Cone Molded Earloop Face Mask | 
| D82795187361 | MASK FORM FIT CONE PINK SMALL | 
| D82795187351 | MASK FORM FIT CONE BLUE REGULAR | 
| D82795187221 | MASK CONE MOLDED SMALL PINK | 
| D82795186891 | MASK CONE MOLDED STANDARD BLUE | 
| D82795151031 | MASK SURGICAL TIE-ON BLUE | 
| D82795004250 | ALGINATE DUSTLESS FAST SET 22LB | 
| D82795004200 | ALGINATE DUSTLESS REGULAR SET 22LB | 
| D82795004150 | ALGINATE DUSTLESS REGULAR SET 1LB | 
| D82795004100 | ALGINATE DUSTLESS FAST SET 1LB | 
| D82794306620 | Temporary Filling Material Syringe 5g | 
| D82794306600 | Temporary Filling Material 18g Jar | 
| 00366467000015 | HEDSTROM FILE W/STOP 21MM #15 DARBY | 
| 40889813000678 | STERILIZATION POUCH 3.5 X 9 | 
| 10889813017958 | 5% Clear Sodium Fluoride Varnish Melon 500ct | 
| 10889813017941 | 5% Clear Sodium Fluoride Varnish Melon 50ct | 
| 10889813017927 | 5% Clear Sodium Fluoride Varnish Mint 500ct | 
| 10889813017910 | 5% Clear Sodium Fluoride Varnish Mint 50ct | 
| 10889813017897 | 5% SODIUM FL VARNISH CARAMEL DARBY | 
| 10889813017880 | 5% SODIUM FL VARNISH CARAMEL DARBY | 
| 10889813017866 | 5% SODIUM FL CLR VARNISH BGUM DARBY | 
| 10889813017859 | 5% SODIUM FL CLR VARNISH BGM DARBY | 
| 10889813013899 | MIRROR SIMPLE STEM PLANE #5 DARBY | 
| 10889813004125 | CARBIDE BUR FG 7803 DARBY | 
| 10889813003234 | SUTURE SILK 3/8 NC-2 3/0 18" DARBY | 
| 10889813002695 | Pit & Fissure Sealant | 
| 10889813002466 | Polysiloxane Bite Super Fast Set Wintermint 50ml CART | 
| 10889813002107 | PVS Impression Material Regular Set Light Body Raspberry 50ML | 
| 10889813001933 | PVS Impression Material Fast Set Light Body Wintermint 50ml | 
| 10889813001926 | PVS Impression Material Regular Set Light Body Wintermint 50ml | 
| 10889813001919 | PVS Impression Material Fast Set Heavy Body Unflav 50ml | 
| 10889813001902 | PVS Impression Material Fast Set Monophase Body Unflav 50ml | 
| 10889813001896 | PVS Impression Material Fast Set Medium Body Unflav 50ml | 
| 10889813001889 | PVS Impression Material Fast Set Light Body Unflavored 50ml | 
| 10889813001773 | Cone Molded Earloop Face Mask | 
| 10889813001766 | MASK FORM FIT CONE PINK SMALL | 
| 10889813001759 | MASK FORM FIT CONE BLUE REGULAR | 
| 10889813001742 | MASK CONE MOLDED SMALL PINK | 
| 10889813001735 | MASK CONE MOLDED STANDARD BLUE | 
| 10889813001728 | MASK SURGICAL TIE-ON BLUE | 
| 10889813001698 | Alginate Substitute Fast Set 50ml CART | 
| 10889813001681 | Alginate Substitute Regular Set 50ml CART | 
| 20889813001428 | SLEEVE T-STYLE HANDLE | 
| 20889813001411 | CHAIR SLEEVE HALF 27.5 x 24 | 
| 20889813001404 | CHAIR SLEEVE FULL 29" X 80" | 
| 20889813001398 | X-Ray Sleeves 15x26 | 
| 20889813001381 | TRAY SLEEVES 10.5" X 14" | 
| 20889813001374 | TRAY SLEEVES 11.5" X 16" | 
| 20889813001367 | Low-speed handpiece sleeves 1.5 x 8 | 
| 20889813001350 | Syringe Sleeves A/W Clear | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  DARBY DENTAL SUPPLY, LLC  85488180  4182856 Live/Registered | Darby Group Companies, Inc. 2011-12-06 |