Night Guard
3D Diagnostix Inc.
3D DIAGNOSTIX INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011429437 | 3011429437 | 3D DIAGNOSTIX INC | 1 | Y | 2026-01-01 | 24 Denby rd Suite 148 Allston MA US 02134 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 186142 | 1176186958 | K202465 | Night Guard | MQC | 2020-11-25 |
| 186142 | 1656047280 | K200908 | iSMILE | NXC | 2020-12-22 |
| 186142 | 1755746607 | ||||
| 186142 | 1871392427 |
Product Codes Associated With Registrations#
PMN#
GUDID#
3DDX Straight Drill Kit - A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
2025-09-10
Tissue Punch - 4.2mm - A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.
2025-09-11
Tapered Drill 4.2X27 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 4.2X24 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 4.2X22 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 4.2X19 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 4.2X17 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 4.2X14 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X28 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X25 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X23 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X20 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X18 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.45X15 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X28 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X25 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X23 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X20 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X18 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Tapered Drill 3.15X15 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x27 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x24 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x22 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x19 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x17 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 04.20x14 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x28 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x25 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x23 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x20 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x18 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.45x15 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x28 - Red - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x25 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x23 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x20 - Blue - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x18 - White - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 03.15x15 - Black - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 02.75x25 - Yellow - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11
Straight Drill LSD 02.75x23 - Green - Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental appliance.
2025-09-11