| Primary Device ID | D002C320003B0 |
| NIH Device Record Key | bb16a054-d125-4f1e-98c2-3e74ca315b9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crescent® Wig-L-Bug |
| Version Model Number | C32003B |
| Catalog Number | C32003B |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@den | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com | |
| Phone | +1(800)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Special Storage Condition, Specify | Between 0 and 0 *For indoor use only, and in temperatures of 5-40 degrees Celsius. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D002C320003B0 [Primary] |
| EFD | AMALGAMATOR, DENTAL, AC-POWERED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-10 |
| Device Publish Date | 2019-04-02 |
| D0029444001 - SmartLite® Pro Modular LED Curing Light | 2025-09-17 |
| D0019064140 - Lucitone | 2025-07-09 Primeprint Lucitone Digital Value Trial Placement A2 |
| D0019064150 - Lucitone | 2025-07-09 Primeprint Lucitone Digital Value Trial Placement A3 |
| D0019064160 - Lucitone | 2025-07-09 Primeprint Lucitone Digital Value Trial Placement B1 |
| D0019064170 - Lucitone | 2025-07-09 Primeprint Lucitone Digital Value Trial Placement B2 |
| D0019064180 - Lucitone | 2025-07-09 Primeprint Lucitone Digital Value Trial Placement BL3 |
| D0016055400 - DENTSPLY Sirona® | 2025-03-31 Overglaze |
| D0016055421 - DENTSPLY Sirona® | 2025-03-25 Overglaze High Flu |