Identity
- Trade Name
- KöR FDA UDI
- Generic Name
- Intraoral dental suction tip holder FDA UDI
- Device Name
- Dental Suction Tip FDA UDI
- Model / Reference
- KöR Suction Tip FDA UDI
- Description
- Dental Suction Tip FDA UDI
Identifiers
- Catalog Number
- 80-1029 FDA UDI
- Primary DI / UDI-DI
- 00850362007144 FDA UDI
- FDA Product Code
- DYN FDA UDI
- GMDN Term
- Intraoral dental suction tip holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
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: Intraoral dental suction tip holder
Kör by Evolve Dental Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral dental suction tip holder.
- Multi-purpose dispensing needle tips - Safco — Safco Dental Supply · Class I
- Multi-purpose dispensing needle tips - Safco — Safco Dental Supply · Class I
- Multi-purpose dispensing needle tips - Safco — Safco Dental Supply · Class I
- Multi-purpose dispensing needle tips - Safco — Safco Dental Supply · Class I
- Multi-purpose dispensing needle tips - Safco — Safco Dental Supply · Class I
- KöR — EVOLVE DENTAL TECHNOLOGIES, INC. · Class I
- KöR — EVOLVE DENTAL TECHNOLOGIES, 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
- Evolve Dental Technologies, Inc.
Sources (1)
- FDA UDI a3111ba1-2541-4447-9efd-20f274c1a1eb 34 fields · synced May 30, 2026