Manufacturer registered with FDA
Combe, Inc.
White Plains, NY, United States. Lists 1 dental device type with FDA across 2 registered establishments, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 41977–1994
- Markets registered in
- 617 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 1976–2026
Registered in 6 markets
Where regulators' registries name Combe, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Combe, Inc. | 4 clearances | 1977–1994 | Below |
| European Union | EUDAMED | Manufacturer | Combe Incorporated | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | COMBE INCORPORATED.COMBE LABORATORIES, INC. · COMBE LABORATORIES, LLC. | 3 | 2005–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Combe Incorporated | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | COMBE INCCOMBE LABORATORIES INC. | 2 | 2003–2010 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｃｏｍｂｅ Ｌａｂｏｒａｔｏｒｉｅｓ， ＬＬＣ | 1 | 2008–2008 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Combe, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Karaya and Ethylene-Oxide Homopolymer Denture AdhesiveKXX · Class 1 | — | Maker | SEA BOND DENTURE ADHESIVE | 1992 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Combe, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Aug 1994 | K942203 | OTC DENTURE CLEANSER | EFT Over the Counter Denture Cleanser |
| 11 Jan 1993 | K925259 | CFR MONOGRAPH | EFT Over the Counter Denture Cleanser |
| 19 Sep 1986 | K863375 | SEA-BOND | KXX Karaya and Ethylene-Oxide Homopolymer Denture Adhesive |
| 24 Jun 1977 | K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | EHS Over the Counter Denture Cushion |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COMBE INCORPORATEDFDA reg. 2412672 | White Plains, NY, United States | Complaint file establishment, Specification developer |
| COMBE LABORATORIES, INC.FDA reg. 1450238 | RANTOUL, IL, United States | Manufacturer |
Other names on FDA records
Combe Laboratories, LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2412672). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.