Silent Nite SILNT
GUDID D745SILNT0
Device for treatment of mild to moderate obstructive sleep apnea
James R. Glidewell, Dental Ceramics, Inc.
Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis| Primary Device ID | D745SILNT0 |
| NIH Device Record Key | dc5b2742-a22d-4665-b7e0-889e63c2e241 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silent Nite |
| Version Model Number | SILNT |
| Catalog Number | SILNT |
| Company DUNS | 021228671 |
| Company Name | James R. Glidewell, Dental Ceramics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D745SILNT0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183270
FDA Product Code
| LRK | Device, anti-snoring |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-01 |
| Device Publish Date | 2019-09-23 |
Devices Manufactured by James R. Glidewell, Dental Ceramics, Inc.
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| D745701123BRX00250 - BruxZir™ TintEFX Coloring Liquid | 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G00 |
| D745701123BRX00260 - BruxZir™ TintEFX Coloring Liquid | 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G0 |
| D745701123BRX00270 - BruxZir™ TintEFX Coloring Liquid | 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G1 |
| D745701123BRX00280 - BruxZir™ TintEFX Coloring Liquid | 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G3 |
Trademark Results [Silent Nite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SILENT NITE 75127485 not registered Dead/Abandoned |
American White Cross, Inc. 1996-07-01 |
 SILENT NITE 75101096 2213243 Live/Registered |
Glidewell Laboratories 1996-05-07 |
 SILENT NITE 72123466 0731070 Dead/Cancelled |
Carter Products, Inc. 1961-07-06 |
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