FDA.reportPublic FDA data

PriZma 3D Bio Splint - Transparent (1000 g)

Primary DI
07898561546982
Brand
PriZma 3D Bio Splint - Transparent (1000 g)
Company
Maquira Industria de Produtos Odontologicos S/A
Model
PriZma 3D Bio Splint
Device description
PRIZMA 3D BIO SPLINT is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of night guards and splints.
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898561546982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898561546982078985615469827898561546982

GMDN Terms

TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
679266866
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07898570928151PriZma 3D Bio Splint Soft - Colorless (250 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928168PriZma 3D Bio Splint Soft - Colorless (500 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928175PriZma 3D Bio Splint Soft - Colorless (1000 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898561546999PriZma 3D Bio Splint - Transparent (500 g)PriZma 3D Bio Splint2025-09-05
07898561547002PriZma 3D Bio Splint - Transparent (250 g)PriZma 3D Bio Splint804837400012025-09-05
07898561547019PriZma 3D Bio Guide - Ambar (1000 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547026PriZma 3D Bio Guide - Ambar (500 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547033PriZma 3D Bio Guide - Ambar (250 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547330PriZma 3D Bio Ortho IBT (1000 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547347PriZma 3D Bio Ortho IBT (500 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547354PriZma 3D Bio Ortho IBT (250 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547736PriZma 3D Bio Crown - BL (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547743PriZma 3D Bio Crown - BL (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547767PriZma 3D Bio Crown - A1 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547774PriZma 3D Bio Crown - A1 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547798PriZma 3D Bio Crown - A2 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547804PriZma 3D Bio Crown - A2 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561548238PriZma 3D Bio Crown - A3 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561549020PriZma 3D Bio Crown Diamond - BL (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05
07898561549037PriZma 3D Bio Crown Diamond A1 (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07908611205742TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x0.76MM - 25UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
07908611205759TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
00815967029380RodinPac-Dent, Inc.KMY2026-03-23
00815967029397RodinPac-Dent, Inc.KMY2026-03-23
06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422563Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422570Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422587Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423065Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
03770020010163FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010187FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
D775JAGFP0AccuguardGreat Lakes Dental Technologies, Ltd.KMY2026-01-16
28906139321169Taglus UltraLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321466Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321473Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321480Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321497Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321527Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321695Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321718Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321749Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321756Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321824Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321831Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321855Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321879Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09