Identity
- Trade Name
- The Orthodontic Store FDA UDI
- Generic Name
- Dental acrylic resin kit FDA UDI
- Device Name
- Ora Pro G2 Lc Adhesive Kit 4/5Gm Syringe FDA UDI
- Model / Reference
- J804K FDA UDI
- Description
- Ora Pro G2 Lc Adhesive Kit 4/5Gm Syringe FDA UDI
Identifiers
- Catalog Number
- J804K FDA UDI
- Primary DI / UDI-DI
- 00840326403570 FDA UDI
- 510(k) Number
- K012673 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dental acrylic resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental acrylic resin kit
The Orthodontic Store by Young Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K012673 also covers:
- Adhere™ Enamel Etch Conditioner — ORTHO SPECIALTIES
- Adhere™ Light Cure Adhesive 5g Syringe — ORTHO SPECIALTIES
- Adhere™ Light Cure Adhesive Kit — ORTHO SPECIALTIES
- Adhere™ Light Cure Adhesive Primer — ORTHO SPECIALTIES
- Adhere™ Light Cure Adhesive Tips — ORTHO SPECIALTIES
- Adhere™ Self Cure Activator — ORTHO SPECIALTIES
- Adhere™ Self Cure Adhesive 5g Syringe — ORTHO SPECIALTIES
- Adhere™ Self Cure Adhesive Kit — ORTHO SPECIALTIES
- Adhere™ Self Cure Adhesive Tips — ORTHO SPECIALTIES
- LockTight™ Auto Mix Band Cement Blue — ORTHO SPECIALTIES
- Locktight™ Auto Mix Band Cement Natural — ORTHO SPECIALTIES
- MAX-BOND — Ortho Pro Dent LLC
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
- Young Innovations, Inc.
Sources (1)
- FDA UDI cd1385b6-703c-49ef-acd5-1706ee443941 36 fields · synced May 31, 2026