americanortho.comBracePaste Fluoride Sealant
American Orthodontics Corp.
AMERICAN ORTHODONTICS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2126683 | 2126683 | AMERICAN ORTHODONTICS | 1 | Y | 2026-01-01 | 3524 Washington Ave SHEBOYGAN WI US 53081 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00190746125591 | Generic Buccal Tubes - WELD TUBE INCONEL UL MOL 022/045OCCL T-10 R6D 4.5MM W/HK | +1(800)558-7687 | info@americanortho.com |
| 00190746125607 | Generic Buccal Tubes - WELD TUBE INCONEL UR MOL 022/045OCCL T-10 R6D 4.5MM W/HK | +1(800)558-7687 | info@americanortho.com |
| 00190746132117 | Generic Buccal Tubes - WELD TUBE MINI MS UL 1ST MOL 018/018AUX/045GING CONV T-10 R8D 3.5MM W/HK | +1(800)558-7687 | info@americanortho.com |
| 00190746135071 | Buccal Tubes - DB TUBE INCONEL LL 1ST MOL 022 T=0 R=0 3.5MM W/HK | +1(800)558-7687 | info@americanortho.com |
| 00190746135088 | Buccal Tubes - DB TUBE INCONEL LR 1ST MOL 022 T=0 R=0 3.5MM W/HK | +1(800)558-7687 | info@americanortho.com |
| 00190746136788 | Gold Tone - WIRE SS GOLD TONE SPOOL 016 30 FEET | +1(800)558-7687 | info@americanortho.com |
| 00190746136795 | Gold Tone - WIRE SS GOLD TONE SPOOL 018 30 FEET | +1(800)558-7687 | info@americanortho.com |
| 00190746170829 | Separators - ELASTOMERIC SEPARATORS RADIO OPAQUE SMALL BLUE .040 THICK 1/8 OD | +1(800)558-7687 | info@americanortho.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 5946 | 1057329034 | K963205 | ALGINMAX, ORTHOCHROME | ELW | 1996-10-29 |
| 5946 | 1456699049 | K961417 | GC FUJI ORTHO | DYH | 1996-05-24 |
| 5946 | 1082597890 | K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB | 1994-03-10 |
| 5946 | 1726443414 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | 1992-07-30 |
| 5946 | 1723567201 | K896249 | BANDTITE GLASS IONOMER CEMENT | EMA | 1990-01-26 |
| 5946 | 1931906123 | K895386 | GLASION | EMA | 1990-04-16 |
| 5946 | 1289018793 | K893542 | DIASTEMA CLOSING KIT | EJF | 1989-06-23 |
| 5946 | 1046836205 | K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS | DYH | 1989-06-12 |
| 5946 | 1086199824 | K891372 | ORTHODONTIC PLASTIC BRACKET | DYW | 1989-03-31 |
| 5946 | 1181967934 | K872569 | TEMREX ETCHING GEL | EBF | 1987-07-21 |
| 5946 | 1720649962 | K831495 | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO | DYH | 1983-07-18 |
| 5946 | 1059941700 | K261840 | BracePaste Prime Plus | DYH | 2026-06-03 |
| 5946 | 1117070567 | K242537 | BracePaste Fluoride Sealant | DYH | 2024-08-27 |
| 5946 | 1413539067 | K232011 | Cleo | NJM | 2023-07-07 |
| 5946 | 1011221632 | K202276 | BracePaste Band and Build LC | DYH | 2020-08-14 |
| 5946 | 1598751424 | K181910 | BracePaste MTP Light Cure Primer | KLE | 2018-10-15 |
| 5946 | 1087043814 | K172953 | Acid Etchant | KLE | 2018-02-06 |
| 5946 | 1337595381 | K160782 | BracePaste Adhesive | DYH | 2016-10-14 |
| 5946 | 1517399984 | K122753 | EMPOWER CLEAR | NJM | 2012-12-14 |
| 5946 | 2032999230 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | ELW | 2012-08-23 |
| 5946 | 1790983149 | K080749 | RADIANCE | NJM | 2008-08-04 |
| 5946 | 1984698567 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | EBZ | 2003-10-21 |
| 5946 | 1684795213 | K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | DYH | 2000-07-21 |
| 5946 | 1084371100 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB | 2000-06-09 |
| 5946 | 1844148783 | ||||
| 5946 | 2011547120 | ||||
| 5946 | 1068885053 | ||||
| 5946 | 1086306673 | ||||
| 5946 | 1192105127 | ||||
| 5946 | 1206575700 | ||||
| 5946 | 1236896962 | ||||
| 5946 | 1267258283 | ||||
| 5946 | 1338807507 | ||||
| 5946 | 1370129332 | ||||
| 5946 | 1505189991 | ||||
| 5946 | 1556003678 | ||||
| 5946 | 1578525614 | ||||
| 5946 | 1595453164 | ||||
| 5946 | 1610231167 | ||||
| 5946 | 1642833911 | ||||
| 5946 | 1705664017 | ||||
| 5946 | 1797313426 | ||||
| 5946 | 1819689756 | ||||
| 5946 | 1843296933 | ||||
| 5946 | 1858227543 | ||||
| 5946 | 1862148780 | ||||
| 5946 | 1870855383 | ||||
| 5946 | 1956577460 | ||||
| 5946 | 1999721336 | ||||
| 5946 | 2019658848 | ||||
| 5946 | 2072166408 |
Product Codes Associated With Registrations#
PMN#
Cleo
American Orthodontics
BracePaste Band And Build LC
American Orthodontics
BracePaste MTP Light Cure Primer
American Orthodontics
Acid Etchant
American Orthodontics
BracePaste Adhesive
American Orthodontics
Wire Sterilization Package With Indicators
AMERICAN ORTHODONTICS
EMPOWER CLEAR
AMERICAN ORTHODONTICS
RADIANCE
AMERICAN ORTHODONTICS
PLASTIC CHAIN
AMERICAN ORTHODONTICS
ORTHODONTIC BITE
AMERICAN ORTHODONTICS
UNI-STICK PLASTIC LIGATURE, MODIFIED
AMERICAN ORTHODONTICS
ORTHODONTIC METAL BRACKET
AMERICAN ORTHODONTICS
MOLAR DISTALIZING ASSEMBLY
AMERICAN ORTHODONTICS
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
AMERICAN ORTHODONTICS
MODIFIED UNI-STICK PLASTIC LIGATURE
AMERICAN ORTHODONTICS
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
AMERICAN ORTHODONTICS
BANDTITE GLASS IONOMER CEMENT
AMERICAN ORTHODONTICS
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
AMERICAN ORTHODONTICS
FORCE II
AMERICAN ORTHODONTICS
UNI-STICK PLASTIC LIGATURES
AMERICAN ORTHODONTICS
KORN MANDIBULAR ADVANCER
AMERICAN ORTHODONTICS
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
AMERICAN ORTHODONTICS
X-RING AND SPEED STIX PLASTIC LIGATURES
AMERICAN ORTHODONTICS
BONDABLE RETAINER AND SPACE MAINTAINER
AMERICAN ORTHODONTICS
MULTIPHASE ORTHODONTIC WIRE
AMERICAN ORTHODONTICS
PLASTIC FORCE MODULE
AMERICAN ORTHODONTICS
X-RING SEPARATORS
AMERICAN ORTHODONTICS
DIASTEMA CLOSING KIT
AMERICAN ORTHODONTICS
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
AMERICAN ORTHODONTICS
MEMORY CHAIN
AMERICAN ORTHODONTICS
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
AMERICAN ORTHODONTICS
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
AMERICAN ORTHODONTICS
MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES
AMERICAN ORTHODONTICS
NICKLE-TITANIUM ORTHODONTIC WIRE
AMERICAN ORTHODONTICS
FILAFLEX ORTHODONTIC WIRE
AMERICAN ORTHODONTICS
JASPER JUMPER KIT
AMERICAN ORTHODONTICS
LIP BUMPER
AMERICAN ORTHODONTICS
ORTHODONTIC COTTON ROLL HOLDERS
AMERICAN ORTHODONTICS
ORTHODONTIC WRAP-AROUND HAWLEY RETAINER
AMERICAN ORTHODONTICS
GUDID#
Separators - ELASTOMERIC SEPARATORS RADIO OPAQUE SMALL BLUE .040 THICK 1/8 OD
2021-06-11
Gold Tone - WIRE SS GOLD TONE SPOOL 018 30 FEET
2018-10-10
Gold Tone - WIRE SS GOLD TONE SPOOL 016 30 FEET
2018-10-10
Buccal Tubes - DB TUBE INCONEL LR 1ST MOL 022 T=0 R=0 3.5MM W/HK
2018-09-25
Buccal Tubes - DB TUBE INCONEL LL 1ST MOL 022 T=0 R=0 3.5MM W/HK
2018-09-25
Generic Buccal Tubes - WELD TUBE MINI MS UL 1ST MOL 018/018AUX/045GING CONV T-10 R8D 3.5MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE INCONEL UR MOL 022/045OCCL T-10 R6D 4.5MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE INCONEL UL MOL 022/045OCCL T-10 R6D 4.5MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE INCONEL UR MOL 018 T-10 R6D 3.5MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE INCONEL UL MOL 018 T-10 R6D 3.5MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE UR 1ST MOL 022 NON-CONV T-14 R14D 4.2MM W/HK
2018-07-05
Generic Buccal Tubes - WELD TUBE UL 1ST MOL 022 NON-CONV T-14 R14D 4.2MM W/HK
2018-07-05
Iconix - COSMETIC ICONIX LP 6.5MM LANG LL CUSP 018 T-7 A+6 R=0 W/HK UNIV
2018-08-03
Iconix - COSMETIC ICONIX LP 6.5MM LANG LR CUSP 018 T-7 A+6 R=0 W/HK UNIV
2018-08-03
Mini Master Series - DB BKT MINI MS V-SLOT LL 1ST BIC 018 T-12 A+2 R=0 OFFSET PAD
2018-06-14
Mini Master Series - DB BKT MINI MS V-SLOT LR 1ST BIC 018 T-12 A+2 R=0 OFFSET PAD
2018-06-06
Mini Master Series - DB BKT MINI MS UL CUSP 018 T-3 A+10 R=0
2018-06-06
Mini Master Series - DB BKT MINI MS UR CUSP 018 T-3 A+10 R=0
2018-06-14
Mini Master Series - DB BKT MINI MS 5.5MM LANG HGW UL BIC 022 T-8 A+4 R=0 OFFSET PAD
2018-06-14
Mini Master Series - DB BKT MINI MS 5.5MM LANG HGW UR BIC 022 T-8 A+4 R=0 OFFSET PAD
2018-06-06
Mini Master Series - DB BKT MINI MS 4.0MM LANG LOWER ANT 022 T-5 A=0 R=0 W/HK UNIV
2018-06-06
Mini Master Series - DB BKT MINI MS 5.0MM LANG LL CUSP 018 T-7 A+6 R=0 W/HK UNIV
2018-08-03
Mini Master Series - DB BKT MINI MS 5.0MM LANG LR CUSP 018 T-7 A+6 R=0 W/HK UNIV
2018-08-03
Mini Master Series - DB BKT MINI MS LL CUSP 022 T-6 A+6 R=0
2018-06-14
Mini Master Series - DB BKT MINI MS LR CUSP 022 T-6 A+6 R=0
2018-06-14
Mini Master Series - DB BKT MINI MS HGW LL 2ND BIC 018 T-9 A+3 R=0 RAISED PAD
2018-06-14
Mini Master Series - DB BKT MINI MS HGW LR 2ND BIC 018 T-9 A+3 R=0 RAISED PAD
2018-06-14
Metal Custom Rx - WELD BKT SS 5.5MM LANG HGW LOWER 2ND BIC 022 T-17 A=0 R=0
2018-08-03
Metal Custom Rx - WELD BKT SS 5.5MM LANG HGW LOWER 1ST BIC 022 T-11 A=0 R=0
2018-08-03
Metal Custom Rx - WELD BKT SS 4.5MM LEWIS HGW UNIV 018 T-17 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS NARROW HGW V-SLOT UNIV 022 T=0 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS SINGLE WIDTH HGW UNIV 022 T=0 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS SINGLE WIDTH STD-DS UNIV 022 T=0 A=0 R=0 CURVED BASE
2018-06-14
Metal Custom Rx - WELD BKT SS SINGLE WIDTH STD-DS UNIV 022 T=0 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS WIDE UNIV 022 T-15 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS MEDIUM UNIV 022 T-20 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS MEDIUM UNIV 022 T-15 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS MEDIUM UNIV 022 T-10 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS MEDIUM UNIV 022 T-5 A=0 R=0
2018-06-14
Metal Custom Rx - WELD BKT SS NARROW UNIV 022 T-10 A=0 R=0
2018-06-14