Identity
- Trade Name
- ORTHOSOURCE FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- Blue Etch 15 gm syringe FDA UDI
- Model / Reference
- 557-617-C FDA UDI
- Description
- Blue Etch 15 gm syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- D911557617C0 FDA UDI
- 510(k) Number
- K861245 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental etching solution
Orthosource by Ortho Source — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental etching solution.
- Dento-Etch — Spident · Class IIa
- Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
- DC Keramik Ätzgel — PRISMAN GmbH · Class I
- MASTER-DENT — DENTONICS, INC.
- OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
- ETCHANT — Pulpdent Corporation · Class II
- Scotchbond™ Universal — 3M Deutschland GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
Cleared under the same submission
K861245 also covers:
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
- ORTHOSOURCE — Ortho Source
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
- Ortho Source
Sources (1)
- FDA UDI 0c36748c-4d5f-4fe7-933f-214211bfc150 34 fields · synced May 30, 2026