Chrysalis Intelligence · Product Codes · EBC

EBC · Sealant, Pit And Fissure, And Conditioner

Dental · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 872.3765
Total clearances
4
2023-07-25 → 2026-05-01
Last 12 months
1
Unique sponsors
4
Medical specialty
Dental
Review panel
DE
Regulation number
872.3765
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Ultradent Product, Inc. 1 0 2023-08-18
Mediclus Co., Ltd. 1 1 2026-05-01
Parkell, Inc. 1 0 2025-08-08
Rizhao Huge Biomaterials Company, Ltd. 1 0 2023-07-25
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
D1351 HCPCS High Dental sealant application for pit and fissure prevention, standard preventive code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-01 K260819 Mediclus Co., Ltd. Any-Com Seal
2025-08-08 K243254 Parkell, Inc. Parkell Pit and Fissure Sealant
2023-08-18 K232498 Ultradent Product, Inc. UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
2023-07-25 K230455 Rizhao Huge Biomaterials Company, Ltd. Enamel Coating Resin