gromaninc.comGROMAN PREPMASTER
GROMAN INC.
GROMAN INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004361444 | 3004361444 | GROMAN INC. | 1 | N | 2026-01-01 | 2000 Banks Rd Ste G1 Coconut Creek FL US 33063 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 30817494020152 | Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 90 micron Aluminum Oxide (Color code marking FUCHSIA) with Regular bend nozzle. | 800-906-9298 | Customerservice@Gromaninc.com |
| 50817494020163 | Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code marking ORANGE) with Regular bend nozzle. | 800-906-9298 | Customerservice@Gromaninc.com |
| 50817494020170 | Etchmaster - PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) with Regular bend nozzle. | 800-906-9298 | Customerservice@Gromaninc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21451 | 1071709780 | K030292 | GROMAN PREPMASTER | KOJ | 2003-04-15 |
| 21451 | 1037049521 | ||||
| 21451 | 1016293143 | ||||
| 21451 | 1104797328 | ||||
| 21451 | 1127853504 | ||||
| 21451 | 1581269785 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KOJ | 1 | 2003-04-15 |
PMN#
GUDID#
SafetyO2 - One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
2023-03-01
SafetyNeb - One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing
2023-03-01
SafetyO2 - One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing
2023-03-01
SafetyNeb - One Kit of SafetyNeb Mask with FacePlate and Nebulizer Tubing
2023-03-01
SafetyFilta - Stick-on Filter for Vented Respiratory Masks to achieve Aerosol Reduction
2023-01-19
Etchmaster - PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code marking ORANGE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 90 micron Aluminum Oxide (Color code marking FUCHSIA) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with SYLC (Color code marking PINK) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 3M Co-Jet (Color code marking BROWN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code marking YELLOW) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with Calcium Carbonate (Color code marking YELLOW) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code marking GREEN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with Sodium Bi-Carbonate (Color code marking GREEN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 50 micron Glass Beads (Color code marking PURPLE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Contra-Angle bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip pre-filled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular bend nozzle,
2016-09-19
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Contra-Angle bend nozzle.
2016-09-27
Etchmaster - PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code marking ORANGE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 90 micron Aluminum Oxide (Color code marking FUCHSIA) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with SYLC (Color code marking PINK) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 3M Co-Jet (Color code marking BROWN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code marking YELLOW) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with Calcium Carbonate (Color code marking YELLOW) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code marking GREEN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with Sodium Bi-Carbonate (Color code marking GREEN) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 50 micron Glass Beads (Color code marking PURPLE) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Small microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 27 micron Aluminum Oxide (Color code marking RED) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Regular bend nozzle.
2016-09-27
Etchmaster - EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color code marking BLACK) with Contra-Angle bend nozzle.
2016-09-27