FDA Registration
Active
🇺🇸 United States
MEDTECH PRODUCTS, INC.
Reg #: 1719513
·
FEI: 1719513
·
Expires 2026
Products
27
Proprietary Names
97
Establishment Types
2
Classifications
26
Registration Details
- Registration Name
- MEDTECH PRODUCTS, INC.
- Registration Number
- 1719513
- FEI Number
- 1719513
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 660 white plains rd
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123849
- PMA Number
- P880056
Owner / Operator
- Firm Name
- PRESTIGE BRANDS HOLDINGS, INC.
- Operator Number
- 9057674
- Address
- 660 White Plains Rd, --
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2017-10-27 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2017-11-09 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2017-10-27 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2017-10-27 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2011-04-28 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2019-06-18 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2017-10-27 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2007-12-14 |
| Detectors And Removers, Lice, (Including Combs) | LJL | Class 1 | General Hospital | No | 2021-04-13 |
| Floss, Dental | JES | Class 1 | Dental | No | 2017-10-27 |
| ORE | No | 2025-07-22 | |||
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2020-02-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2020-02-10 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-01-05 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2011-04-28 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2017-10-27 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2017-10-27 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2017-03-23 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2008-01-21 |
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | Class 1 | Dental | No | 2022-01-20 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2021-04-13 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-04-13 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2020-02-26 |
| Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | KOL | Class 1 | Dental | No | 2011-09-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-04-26 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2017-10-27 |
| Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | NKJ | Class 1 | Dental | No | 2020-02-10 |
Proprietary Names
Dentek New Comfort-Fit Dental Guard
Dentek Platinum Ultimate Comfort Dental Guard
Compound W Nitro-Freeze
Compound W NitroFreeze XL
Dentek Dental First Aid Kit
Dentek Complete Dental Repair Kit
Thin Set Cap and Crown Cement
Temparin Max Hold
Dentek Custom Comfort Dental Guard
Dentek Maximum Protection Dental Guard
Dentek Wide Brush with Fluoride
Dentek Easy Brush with Fluoride
Dentek Sensitive Easy Brush
The Doctor's Orapik Traveler
Dentek Dental Scaler
Dentek Oral Care Kit
Dentek Dental Pick
Stye Warming Eye Compress
Comfort Clean Tongue Cleaner
Orabrush Tongue Cleaner
Dentek Tongue Cleaner
Dentek Gum Stimulator
Dentek Ultimate Comfort Picks
Dentek Pocket Picks
Comfort Fit Dental Guard
COMPOUND W FREEZE-OFF
WARTNER FREEZING WART REMOVER
Compound W Freeze Off Plantar
Wartner Plantar
Nix Ultra Lotion
Dentek Fresh & White Floss Picks
Dentek Fresh Clean Floss Picks
Dentek Triple Clean Floss Picks
Dentek On-the-Go Floss Picks
Dentek Complete Clean Back Teeth Floss Picks
Dentek Floss Threader
Dentek Comfort Clean Floss Picks
Dentek Complete Clean Floss Picks
Dentek Essentials Silk Floss Picks
Dentek 3-in-1 Interdental Cleaners
Dentek Kids Fun Flossers
Dentek Sensitive Floss Picks
Dentek Kids Fun Flosser Handle
Dentek Comfort Clean Easy Reach Floss Picks
Dentek Cross Flosser
DenTek Fresh Breath Floss Pick
Compound W Dual Power
Compound W Nitro Freeze Skin Tag Remover
Uristat Test Strips
Compound W Freeze Off Advanced
Compound W Freeze Off for Kids
Compound W Gel plus Conseal Patch
The Doctor's NightGuard Advanced Comfort
Dentek Fresh Protect Dental Guard
Efferdent Overnight Whitening
Efferdent Denture Cleanser PM
Efferdent Complete Clean Denture Cleanser
Efferdent Coffee and Tea
Efferdent Denture Cleanser Coffee and Tea
Efferdent Denture Cleanser Original
Efferdent Denture Cleanser Plus
Efferdent Fresh and Clean
Fresh Guard by Efferdent Soaks
Dentek Wax for Braces
Dentek Mouth Mirror
Monistat Complete Care Vaginal Health Test
Clear Eyes Contact Lens Relief
Effergrip Denture Adhesive
Efferdent Denture Bath Kit
Little Remedies Nasal Syringe
Murine Ear Syringe
Debrox Ear Syringe
Compound W Freeze Off Skin Tag Remover
Compound W Skin Tag Remover
The Doctor's Nightguard
Dentek Easy Brush Tight
Dentek Easy Brush Wide
Dentek Slim Brush
Dentek Dual Action Brush
Dentek Deep Clean Bristle Picks
Dentek Scrub Betweens
Dentek Easy Brush Standard
Dentek Easy Brush Sensitive
Dentek Easy Brush
The Doctor's Brushpicks
DenTek Ultimate Dental Guard
Effergrip
SteriLid Foam Cleanser
Compound W Complete Wart Kit
Dental Applicator
Boudreaux's Butt Brush
Nix Ultra
Nix Complete Lice Elimination Kit; Nix Electronic Lice Comb
Nix Premium Metal Comb
Nix Ultra Shampoo
Dentek Ready-Fit Dental Guards
EZO Denture Cushions (Upper and Lower)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198