Identity
- Trade Name
- Pomee FDA UDI
- Generic Name
- Dental spatula, reusable FDA UDI
- Device Name
- Cement Spatula #11s (313) FDA UDI
- Model / Reference
- 713-110 FDA UDI
- Description
- Cement Spatula #11s (313) FDA UDI
Identifiers
- Catalog Number
- 713-110 FDA UDI
- Primary DI / UDI-DI
- G1577131100 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Dental spatula, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental spatula, reusable
Pomee by Pomee Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental spatula, reusable.
- Power Dental USA — Power Dental USA, Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- CERVICAL MATRIX — TDV DENTAL LTDA · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- Quinelato — Schobell Industrial Ltda · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pomee Corporation
Sources (1)
- FDA UDI 5b70e236-5de8-454b-9a8c-9cbcecfb56fd 34 fields · synced Jun 8, 2026