FDA.reportPublic FDA data

AdDent

Primary DI
D8691300001
Brand
AdDent
Company
ADDENT, INC.
Model
Compex HD
Catalog number
130000
Device description
The Compex HD unit is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre-Loaded Tip) to 155 degrees F (68 degrees C).
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGOComposite Resin Warmer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGOComposite Resin WarmerDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182017000Compex HDAddent, Inc.2019-04-29QGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8691300001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material cartridge-plunging applicator, single-componentA hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2037780200dpinto@addent.com

Regulatory Flags#

DUNS number
099490679
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D86911008001AdDentMicrolux 21100802017-06-01
D8691120010AdDentOraBlu1120012017-06-01
D86962000706AdDentMicrolux6200072017-06-01
D8691100000AdDentCalset1100002017-06-01
D86911009002AdDentBio/Screen1100902017-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998102578Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998102608Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998102615Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998327667Solventum™ Filtek™Solventum Germany GmbHQGO2025-04-03
040350772000043M™3M Deutschland GmbHQGO2024-12-02
10818207022162Phasor KitVista DentalQGO2022-09-01
10818207023107Vista 240V 6cc Syringe WarmerVista DentalQGO2022-09-01
10818207023114Vista 220V 12cc Syringe WarmerVista DentalQGO2022-09-01
10818207023121Vista 120V 6cc Syringe WarmerVista DentalQGO2022-09-01
10818207023138Vista 120V 12cc Syringe WarmersVista DentalQGO2022-09-01
10818207022155Phasor NoseconesVista DentalQGO2022-09-01
00818207022165Phasor KitVista DentalQGO2022-09-01
00818207023100Vista 240V 6cc Syringe WarmerVista DentalQGO2022-09-01
00818207023117Vista 220V 12cc Syringe WarmerVista DentalQGO2022-09-01
00818207023124Vista 120V 6cc Syringe WarmerVista DentalQGO2022-09-01
00818207023131Vista 120V 12cc Syringe WarmersVista DentalQGO2022-09-01
E22191461VisCalor DispenserVOCO GmbHQGO2019-11-26
E22199951VisCalor DispenserVOCO GmbHQGO2019-11-26
E22191431VisCalor DispenserVOCO GmbHQGO2019-05-10
E22191441VisCalor DispenserVOCO GmbHQGO2019-05-10
E22191451VisCalor DispenserVOCO GmbHQGO2019-05-10