FDA.reportPublic FDA data

PriZma 3D Bio Guide - Ambar (1000 g)

Primary DI
07898561547019
Brand
PriZma 3D Bio Guide - Ambar (1000 g)
Company
Maquira Industria de Produtos Odontologicos S/A
Model
PriZma 3D Bio Guide
Catalog number
80483740003
Device description
PRIZMA 3D BIO GUIDE is a UVA/UVB light cured resin exclusively for use in 3D printers. Indicated for the manufacted of surgical guides for implants and others.
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898561547019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898561547019078985615470197898561547019

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
679266866
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
07898561549044PriZma 3D Bio Crown Diamond - A2 (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235517Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235524Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235531Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235548Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235555Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
04260516875448SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875455SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875462SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
04260516878197SIC invent Dental Implant SystemsSIC invent AGNDP2026-08-18
07290108810639Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810646Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810653Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810684Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810691Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810707Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810714Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810721Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810738Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810745Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810752Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18
07290108810769Plastic Castable AbutmentNORIS MEDICAL LTDNDP2026-08-18