Identity
- Trade Name
- iSmile FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Tray Sleeve Size F 7-1/2" x 10-1/2" FDA UDI
- Model / Reference
- 45-0045 FDA UDI
- Description
- Tray Sleeve Size F 7-1/2" x 10-1/2" FDA UDI
Identifiers
- Catalog Number
- 45-0045 FDA UDI
- Primary DI / UDI-DI
- 00816419022058 FDA UDI
- 510(k) Number
- K190484 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment/instrument drape, single-use
iSmile by Ismile Dental Products Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment/instrument drape, single-use.
- Plasdent — PLASDENT CORP. · Class II
- Exact Medical Manufacturing, Inc. — Exact Medical Manufacturing · Class II
- Proteger — DAS Medical International SRL · Class II
- Machine Bag — Dynarex Corp. · Class I
- TIDIShield — TIDI PRODUCTS, LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- Plasdent — PLASDENT CORP. · Class II
- Probe Cover — Advance Medical Designs, Inc. · Class II
Cleared under the same submission
K190484 also covers:
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
- iSmile — ISMILE DENTAL PRODUCTS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ismile Dental Products Inc.
Sources (1)
- FDA UDI ae1965da-8bdb-49fa-814f-78762e37f90a 36 fields · synced May 30, 2026