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3D DIAGNOSTIX, INC.

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 004512027

Catalogue (83)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Straight Drill LSD 01.95x20 - Blue	Dental drill bit, reusable / Straight Drill LSD 01.95x20 - Blue	FDA UDI	Class I	Active
3DDX Sleeve 510-410-35L	Drilling template guide-sleeve /510-410-35L	FDA UDI	Class I	Active
Straight Drill LSD 02.75x15 - Black	Dental drill bit, reusable / Straight Drill LSD 02.75x15 - Black	FDA UDI	Class I	Active
Straight Drill LSD 03.45x20 - Blue	Dental drill bit, reusable / Straight Drill LSD 03.45x20 - Blue	FDA UDI	Class I	Active
Straight Drill LSD 04.20x17 - White	Dental drill bit, reusable / Straight Drill LSD 04.20x17 - White	FDA UDI	Class I	Active
3DDX Sleeve 220-120-4L	Drilling template guide-sleeve /220-120-4L	FDA UDI	Class I	Active
3DDX Sleeve 255-155-7L	Drilling template guide-sleeve /255-155-7L	FDA UDI	Class I	Active
Straight Drill LSD 04.20x22 - Green	Dental drill bit, reusable / Straight Drill LSD 04.20x22 - Green	FDA UDI	Class I	Active
Straight Drill LSD 01.95x15 - Black	Dental drill bit, reusable / Straight Drill 01.95x15 - Black	FDA UDI	Class I	Active
Straight Drill LSD 01.95x28 - Red	Dental drill bit, reusable / Straight Drill LSD 01.95x28 - Red	FDA UDI	Class I	Active
3DDX Sleeve 340-240-4L	Drilling template guide-sleeve /340-240-4L	FDA UDI	Class I	Active
Straight Drill LSD 03.15x15 - Black	Dental drill bit, reusable / Straight Drill LSD 03.15x15 - Black	FDA UDI	Class I	Active
3DDX Sleeve 310-210-4L	Drilling template guide-sleeve /310-210-4L	FDA UDI	Class I	Active
3DDX Tapered Drill Kit	Dental/maxillofacial surgical procedure kit, non-medicated, reusable / Tapered	FDA UDI	Class I	Active
Tapered Drill 4.2X19 - Blue	Dental Drill bit, reusable / Tapered Drill 4.2X19 - Blue	FDA UDI	Class I	Active
Tapered Drill 3.45X23 - Green	Dental Drill bit, reusable / Tapered Drill 3.45X23 - Green	FDA UDI	Class I	Active
Straight Drill LSD 02.75x25 - Yellow	Dental drill bit, reusable / Straight Drill LSD 02.75x25 - Yellow	FDA UDI	Class I	Active
3DDX Fixation Pin - 1.5mmx20mm	Fixture/appliance dental drill bit, reusable / 1.5mmx20mm	FDA UDI	Class I	Active
Tapered Drill 3.15X18 - White	Dental Drill bit, reusable / Tapered Drill 3.15X18 - White	FDA UDI	Class I	Active
iSMILE Dental Aligners	Orthodontic Aligners	FDA UDI	Class II	Active
Straight Drill LSD 04.20x27 - Red	Dental drill bit, reusable / Straight Drill LSD 04.20x27 - Red	FDA UDI	Class I	Active
Tapered Drill 3.45X25 - Yellow	Dental Drill bit, reusable / Tapered Drill 3.45X25 - Yellow	FDA UDI	Class I	Active
Tapered Drill 3.45X15 - Black	Dental Drill bit, reusable / Tapered Drill 3.45X15 - Black	FDA UDI	Class I	Active
Straight Drill LSD 01.95x23 - Green	Dental drill bit, reusable / Straight Drill LSD 01.95x23 - Green	FDA UDI	Class I	Active
Straight Drill LSD 03.45x28 - Red	Dental drill bit, reusable / Straight Drill LSD 03.45x28 - Red	FDA UDI	Class I	Active
Straight Drill LSD 03.45x25 - Yellow	Dental drill bit, reusable / Straight Drill LSD 03.45x25 - Yellow	FDA UDI	Class I	Active
Tissue Punch - 4.2mm	Dental soft-tissue coring punch, reusable / Tissue Punch - 4.2mm	FDA UDI	Class I	Active
Straight Drill LSD 02.75x23 - Green	Dental drill bit, reusable / Straight Drill LSD 02.75x23 - Green	FDA UDI	Class I	Active
3DDX Sleeve 606-506-35L	Drilling template guide-sleeve /606-506-35L	FDA UDI	Class I	Active
3DDX Side Opening Kit Keys - 2.0/2.8	Surgical drill chuck key _ 2.0/2.8	FDA UDI	Class I	Active
Straight Drill LSD 01.95x25 - Yellow	Dental drill bit, reusable / Straight Drill LSD 01.95x25 - Yellow	FDA UDI	Class I	Active
Night Guard	K202465	FDA 510(k)	U	Active
iSMILE	K200908	FDA 510(k)	Class II	Active

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