Identity
- Trade Name
- iSmile FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Handpiece Sleeve 1" x 8" Clear FDA UDI
- Model / Reference
- 45-0009 FDA UDI
- Description
- Handpiece Sleeve 1" x 8" Clear FDA UDI
Identifiers
- Catalog Number
- 45-0009 FDA UDI
- Primary DI / UDI-DI
- 00816419021969 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
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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 e8cf69b9-b945-4606-9c0c-c079c59bdf6d 36 fields · synced May 30, 2026