addent.comCompex HD
AdDent, Inc.
ADDENT, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003694926 | 3003694926 | ADDENT, INC. | 1 | N | 2026-01-01 | 43 Miry Brook Rd DANBURY CT US 06810 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| D8691100000 | AdDent - Calset warmer for composite materials/anaesthesia and instruments. | 2037780200 | dpinto@addent.com |
| D86911008001 | AdDent - The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux 2 applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. | 2037780200 | dpinto@addent.com |
| D86911009002 | AdDent - The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities. | 2037780200 | dpinto@addent.com |
| D8691120010 | AdDent - The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation. | 2037780200 | dpinto@addent.com |
| D8691300001 | AdDent - 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). | 2037780200 | dpinto@addent.com |
| D86962000706 | AdDent - The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening. | 2037780200 | dpinto@addent.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61185 | 1709131928 | K182017 | Compex HD | QGO | 2019-04-29 |
| 61185 | 1920587539 | K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | NXV | 2012-07-24 |
| 61185 | 1594002042 | K082668 | BIO-SCREEN | NXV | 2009-01-23 |
| 61185 | 1937799598 | K062961 | MICROLUX TRANSILLUMINATOR | NTK | 2007-02-08 |
| 61185 | 1999007988 | K061395 | CALSET COMPOSITE HEATER | EBZ | 2006-06-23 |
| 61185 | 1756926279 | K041614 | MICROLUX DL | EAZ | 2005-04-04 |
| 61185 | 1829192783 | ||||
| 61185 | 1004138393 | ||||
| 61185 | 1545627405 | ||||
| 61185 | 1550026808 | ||||
| 61185 | 1592373529 |
Product Codes Associated With Registrations#
PMN#
MICROLUX/DL MICROLUX/BLU BIO/SCREEN
ADDENT, INC.
BIO-SCREEN
ADDENT, INC.
MICROLUX TRANSILLUMINATOR
ADDENT, INC.
CALSET COMPOSITE HEATER
ADDENT, INC.
MICROLUX DL
ADDENT, INC.
GUDID#
AdDent - 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).
2026-04-22
AdDent - The Microlux 2 Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux 2 applications include an accessory for Proximal Caries detection, and Oral Cancer Screening.
2017-06-01
AdDent - The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
2017-06-01
AdDent - The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening.
2017-06-01
AdDent - Calset warmer for composite materials/anaesthesia and instruments.
2017-06-01
AdDent - The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities.
2017-06-01