Product code DYH— Dental
PORCELAIN PRIMER
- Classification name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device class
- Class 2
- Regulation
- 21 CFR 872.3750
- Advisory panel
- Dental
- Total cleared
- 194
- First cleared
- Most recent
Market context for product code DYH
FDA has cleared devices under product code DYH between 1976 and 2026, filed by 65 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2016
- 2015
- 2013
- 2012
- 2011
- 2010
Top applicants under product code DYH
Recent clearances under product code DYH
1–100 of 194- K261129 — OrthoFit
- K261840 — BracePaste Prime Plus
- K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- K242537 — BracePaste Fluoride Sealant
- K234043 — 3M Transbond Orthodontic Adhesive
- K231817 — AlignerFlow LC
- K214054 — TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
- K210115 — FiteBac CC OrthoSeal
- K192682 — Orthocem, Ortho Bite
- K202276 — BracePaste Band and Build LC
- K193388 — GlassLok Kits, GlassLok Powder, GlassLok Liquid
- K183147 — BrackFix
- K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP
- K160782 — BracePaste Adhesive
- K161684 — Quantum LB
- K150128 — GC Ortho Connect, GC Ortho Etching Gel
- K143667 — GC KommonBase
- K142886 — DMRC Self-Cure Bracket Adhesive One Step and Primer
- K142881 — DMRC Dual Cure Orthodontic Band Cement
- K142880 — DMRC Light Cure Orthodontic Adhesive System
- K123348 — CLEAR ALIGNER ADHESIVE
- K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE
- K113401 — ORTHO-1(NOT FINALIZED)
- K113197 — APC FLASH-FREE ADHESIVE
- K111814 — PADLOCK
- K111696 — OPAL BAND CEMENT
- K101951 — LIGHT CURE RETAINER
- K100536 — TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
- K100301 — OPAL BOND FLOW
- K094006 — OPAL BOND MV
- K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
- K090355 — OPAL SEAL
- K083051 — FLOWTAIN & FLOWTAIN LV
- K080445 — LION SE ONE STEP ORTHODONTIC ADHESIVE
- K080724 — GC OPB-100
- K081291 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
- K073588 — GC MODELS OPA-100 AND JC-50
- K073697 — TRANSBOND SUPREME ADHESIVE
- K072978 — TENDER ORTHO BOND-ENA BOND-ENA ETCH
- K072830 — RM BOND, MODEL J032
- K071590 — THERMA-CURE
- K061252 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
- K061481 — GRENGLOO
- K053379 — RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
- K050750 — LC BRACKET ADHESIVE SYSTEM
- K042422 — D3 CHROMA
- K040375 — IDEAL 1 ORTHODONTIC BAND CEMENT
- K040547 — AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
- K040548 — AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
- K033703 — IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
- K033551 — EVOLVE
- K030644 — CONTEC DUO, CONTEC LC, CONTEC LCR
- K032195 — DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
- K032407 — OPTIBAND LC
- K032042 — ENVISION
- K030977 — DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
- K030980 — DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
- K031420 — S & C -BRACKET ADHESIVES
- K030036 — TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
- K022224 — COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
- K020502 — SOLO ORTHO 3
- K020648 — GRIDLOCK 195 ADHESIVE
- K020578 — GC FUJI ORTHO BAND PASTE PAK
- K020394 — APC PLUS ADHESIVE
- K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
- K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
- K014142 — UNITE BONDING ADHESIVE
- K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
- K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
- K012673 — PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
- K012032 — FIRST SPEP
- K010544 — VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
- K011521 — ORTHO VLC; ORTHO VLC CAPSULE
- K001881 — IMPROVED ENLIGHT LV
- K001446 — LIGHT-CURED ORTHODONTIC BAND CEMENT
- K001048 — LIGHT BOND (QUICK CURE)
- K994309 — SOLO ORTHO 2
- K990743 — SOLO ORTHO
- K981036 — SMARTBOND
- K990252 — SOLO PLUS ORTHO
- K984362 — ENLIGHT LV
- K984217 — ENLIGHT-2
- K981461 — GC FUJI ORTHO LC
- K972890 — ENLIGHT (TENTATIVE NAME)
- K962946 — ORTHO-ONE
- K961417 — GC FUJI ORTHO
- K955329 — RESILIENCE M5 PROTECTION PLUS
- K954373 — AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
- K954374 — AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
- K954372 — AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
- K954244 — AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
- K954333 — AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
- K952856 — LIGHT-CURE PC
- K952855 — PC-LOCK
- K952857 — PRO-LOCK
- K952858 — LIGHT-CURE
- K953217 — PULPDENT TOUCHDOWN
- K952854 — PULPDENT GLASS IONOMER CEMENTS
- K952643 — RIGHT-ON ADHESIVE BOUDING SYSTEM
- K951380 — VILA PC
Data sourced from openFDA. This site is unofficial and independent of the FDA.